Spine Instruments Instructions for Use and Reprocessing Instructions

0902-90-186 Rev. A 2797

en

Instructions for Use and Reprocessing Instructions Some products may not be licensed in all jurisdictions.

Many instruments are intended for use for a specific purpose. It is essential that the surgeon and operating room staff is fully conversant with the appropriate surgical technique for the instruments and associated implants, if any. Most instrument systems include inserts/trays and a container(s). Indications and Contra-indications are based on implantable devices or procedure rather than the instruments. Specific Indications and Contra-indications can be found in the respective implant IFUs.

Patient Target Group

There are no restrictions for patient age or physiology, when the product is used in respect to the indications, contra-indications and in consideration of the health condition of the patient.

Intended User

DePuy Synthes Spine instruments are intended to be used by qualified health care professionals such as surgeons, physicians, operating room staff and professionals involved in preparation of the device. All personnel handling the device should be fully aware of the IFU. Expected Clinical Benefits of DePuy Synthes Spine Instruments are general preparation of the surgical site. DePuy Synthes has established the performance and safety of DePuy Synthes Spine Instruments and performs as intended when used according to their instructions for use. DePuy Synthes Spine Instruments do not have an indefinite functional life. All reusable instruments are subjected to repeated stresses related to bone contact, impaction, routine cleaning, and sterilization processes. Instruments should be carefully inspected before each use to ensure that they are fully functional. Scratches or dents can result in instrument

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breakage or soft tissue injury. Care should be taken to remove any debris, tissue or bone fragments that may collect on the instrument. For further information on end of life refer to End of Life indicators at www.e-ifu.com/referenced-documents. Metal instrument or its fragments can be located by means of an external imaging device (e.g., X-ray, CT scanner). The limits of accuracy for instruments with a measuring function will vary between instruments; the greatest limit of accuracy for an instrument with a measuring function is ± 2%. Section 1 outlines information for cleaning and sterilization of single-use non-sterile devices. Section 2 outlines information for cleaning and sterilization of reusable surgical instruments.

SECTION 1. FOR SINGLE USE NON‑STERILE DEVICES THE FOLLOWING INSTRUCTIONS APPLY:

SINGLE-USE DEVICES SHOULD NOT BE REUSED. Reuse can compromise device performance and patient safety. Reprocessing or resterilization may lead to changes in material characteristics, which may impact the device performance and patient safety. Reuse of single-use devices can also cause cross-contamination leading to patient infection. Devices supplied non-sterile must be cleaned and sterilized prior surgical use. Refer to Limitations on Processing section for further information on cleaning and sterilization. All single-use devices and materials should be removed and discarded in compliance with local policies.

SECTION 2. FOR REUSABLE INSTRUMENTS, THE FOLLOWING INSTRUCTIONS APPLY:

These reprocessing instructions apply to Reusable surgical instruments supplied by DePuy Synthes intended for reprocessing in a health care facility setting.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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These reprocessing instructions have been validated as being capable of preparing reusable DePuy Synthes instruments for reuse. It is the responsibility of the reprocessor to ensure that the reprocessing is actually performed using appropriate equipment, materials, and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation by the reprocessor from these instructions should be evaluated for effectiveness and potential adverse consequences. Please telephone DePuy Synthes Customer Service at +1 (508) 880-8100 if you need additional assistance.

Warnings and Cautions

These instructions are provided for the processing of heat‑resistant, immersible, critical medical devices, unless otherwise noted on specific product inserts. Product specific inserts are given priority over these instructions. This can include heat-sensitive devices and certain power (air- or electric-driven) tool designs that are provided with specific cleaning and sterilization instructions. Consult the product specific instructions for processing in these cases. The instructions provided are given as guidance for medical device processing and have been validated by the manufacturer. It is the responsibility of the healthcare facility to ensure that processing is performed using the required equipment, materials and personnel at a defined processing area. This will include the handling of devices during transportation, processing and storage prior to surgical use. Those using these instructions should be qualified personnel with documented training and competency in accordance with local procedures, guidelines, and standards. Surgically used instruments can be considered biohazard and facilities should ensure that transport and handling procedures comply with local regulations and guidelines. Sterile, single use implants must not be reprocessed or reused. Sterile implants are labelled as single use and have not been validated for reprocessing. Non-sterile implants must be processed prior to use in accordance with these processing instructions. They may be subjected to reprocessing in accordance with these processing instructions, but they must be discarded following direct patient contact or use. Reusable, non-sterile surgical instruments are required to be cleaned, inspected and sterilized prior to surgical use. Care should be taken in the handling and cleaning of sharp devices.

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All devices must be thoroughly cleaned and inspected prior to sterilization. Long, narrow lumens, blind holes, moving and intricate parts require particular attention during cleaning and inspection. During cleaning, only use detergents that are labelled for use on medical devices and in accordance with the manufacturer’s instructions (e.g., temperature, contact time, and rinse time). Cleaning agents with a used dilution pH of within 7–9 are recommended. Highly alkaline conditions (pH>10) can damage components / devices, such as aluminum materials. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products). Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes. Instruments should be carefully inspected before each use to ensure that they are functional. Scratches, dents or other damage can result in instrument breakage or tissue injury. In the event of instrument breakage during use, ensure that all device fragments that may have entered the surgical site are removed prior to completion of the procedure as patient injury may result. Instruments must be cleaned separately from instrument trays and cases. Instrument trays and cases are designed as an organizational tool in preparation for sterilization, storage and surgical use. Non-sterile implant sets may be processed in their trays provided. Automated equipment, including washer-disinfectors and steam sterilizers must be installed, maintained and operated in accordance with manufacturer’s instructions. Do not exceed 140°C (284°F) during reprocessing steps. For patients with, or suspected with, Creutzfeldt-Jakob disease (CJD), variant CJD or other transmissible spongiform encephalopathy (TSE) and related infections, it is recommended to treat the patient using single-use instruments. Safely dispose of all devices used in accordance with local procedures and guidelines.

Adverse Effects

The following list of adverse effects may be associated with the use of these devices: • Patient Infection • Adverse Local Tissue Reaction • Soft Tissue Damage Reusable devices must be cleaned and sterilized before each use or it could lead to patient infection.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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For additional adverse effects, please refer to related product specific Instructions for Use (System/Implant Instructions for Use).

Limitations on Processing

Repeated processing cycles in compliance with these instructions for use have minimal effects on device life and function. Instruments do not have an indefinite functional life. End of life of devices is determined by wear and damage due to surgical use and handling. Evidence of damage and wear on a device may include but is not limited to corrosion (i.e., rust, pitting), discoloration, excessive scratches, flaking, wear and cracks. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used. Non-sterile implants must be discarded following patient use. Any implant with evidence of damage, such as due to handling or processing must be discarded.

Step 1: Point of Use Care

Ensure that no instruments or parts are left in the surgical site prior to closure as patient injury may result. All single use devices and materials should be removed and discarded in compliance with local policies. The drying of gross soil (blood, tissue and/or debris) on devices following surgical use should be avoided. It is preferred that gross soil is removed from devices following use and in preparation for transportation to a processing area. Gross soil can be removed using sponges, cloths, or soft brushes. Water and/or cleaning detergents (labelled for use on medical devices) may be used. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodineor chlorhexidine-containing products. Flush all lumens, blind holes, small clearances, and moving and intricate parts with water (or detergent solution) to prevent the drying of soil and/or debris. If gross-soil cannot be removed at the point of use, the devices should be transported to prevent drying (e.g., covered with a towel dampened with purified water) and cleaned as soon as possible at a designated processing area. Surgical cement should be removed from devices during surgical use and prior to setting. When cement hardens, it will typically require physical methods to remove. Chemical solvents should not be used. Hardened cement may be removed with an approved stylus or removing tool, but these may damage devices.

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Step 2: Containment and Transportation

Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with local policies.

Step 3: Cleaning

Preparation before Cleaning

It is recommended that devices should be reprocessed as soon as is reasonably practical following surgical use. Instruments must be cleaned separately from instrument trays and cases. Non-sterile implants may be cleaned and disinfected in the provided implant trays. Care should be taken in the handling and cleaning of sharp devices. These are recommended to be cleaned separately to reduce risks of injury. Multi-part or complex instruments may require disassembly for cleaning. Refer to any technique guides or other supplemental information for specific device disassembly and/or reassembly instructions. Any devices with moving parts (e.g., ratchets, box locks, hinges or actuated parts) need to be actuated during manual cleaning and rinsing to ensure access of the cleaning process. All devices with lumens need to be manually flushed to remove debris and brushed thoroughly using appropriately sized soft-bristled brushes and twisting action. Brush size should be approximately the same diameter of the lumen to be cleaned. Using a brush that is too big or too small for the diameter of the lumen/cannulation may not effectively clean the lumen. Refer to any technique guides or other supplemental information for specific device lumen diameters. After brushing, rinse with water by flushing and blow clean compressed air through all lumens. NOTE: Two cleaning methods are provided, a Manual and an Automated Method, and at least one shall be performed.

Cleaning: Manual

1. Prepare a neutral or mild alkaline cleaning solution (pH 7–9) in accordance with the detergent manufacturer’s instructions. The temperature of the solution should be ≤40°C (104°F) for manual cleaning. NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used, but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 2. Immerse devices and parts in the detergent solution, and soak for a minimum of 5 minutes.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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3. While immersed, use a soft non-metallic bristle brush (plastic bristles, like nylon) or sponge to thoroughly clean all traces of blood and debris from all device surfaces for a minimum of one minute. 4. Ensure all lumens are thoroughly brushed. Push the brush through the entire length of the lumen using a twisting motion to remove debris from both ends for a minimum of one minute. 5. During cleaning, actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Ensure all lumens, blind holes, small clearances, and moving and intricate parts are flushed for a minimum of one minute. 6. Rinse all devices by immersion in ambient, <40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50 ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 7. Completely submerge the devices in an ultrasonic bath prepared with a neutral or mild alkaline pH detergent (pH 7–9), prepared in accordance with the manufacturer’s instructions. Use a large syringe (50 ml or greater) flush all lumens, blind holes, small clearances, and moving and intricate parts with the detergent solution to minimize the formation of air pockets or bubbles. NOTE: Ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of ultrasonic cleaning. 8. Ultrasonically clean the device components for a minimum of 10 minutes in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included 40 kHz at 25°C for 10 minutes. 9. Rinse all devices by immersion in ambient, <40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50 ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 10. Remove the devices and repeat the rinsing using in ambient, <40°C (104°F) critical water (high purity water generated by processes such as RO, deionization or distillation) for at least 15 seconds.

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11. Remove and dry device using a clean, soft, lint-free cloth or clean compressed air. Ensure that all lumens and articulated areas are dried using compressed air.

Cleaning: Automated

1. Prepare a neutral or mild alkaline cleaning solution (pH 7–9) in accordance with the detergent manufacturer’s instructions. The temperature of the solution should be ≤40°C (104°F) for manual cleaning. NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used, but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 2. Immerse devices and parts in the detergent solution, and soak for a minimum of 5 minutes. 3. While immersed, use a soft non-metallic bristle brush (plastic bristles, like nylon) or sponge to thoroughly scrub all traces of blood and debris from all device surfaces for at least one minute. 4. Ensure all lumens are thoroughly brushed. Push the brush through the entire length of the lumen using a twisting motion to remove debris from both ends for at least one minute. 5. During cleaning, actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Ensure all lumens are flushed for at least one minute. 6. Rinse all devices by immersion in ambient, <40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50 ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 7. Completely submerge the devices in an ultrasonic bath prepared with a neutral or mild alkaline pH detergent (pH 7–9), prepared in accordance with the manufacturer’s instructions. Use a large syringe (50 ml or greater) flush all lumens, blind holes, small clearances, and moving and intricate parts with the detergent solution to minimize the formation of air pockets or bubbles. NOTE: Ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of ultrasonic cleaning.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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8. Ultrasonically clean the device components for a minimum of 10 minutes in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included 40 kHz at 25°C for 10 minutes. 9. Rinse all devices by immersion in ambient, <40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50 ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 10. Load the device components in the washer-disinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens have maximum exposure to detergents and rinse water and can drain freely. 11. Automated washing shall be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and -2, or to an equivalent standard. Automated washing can be included as part of a validated washing, disinfection, and/or drying cycle in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included:

Phase

Recirculation Time (minutes)

Pre-wash

2

Enzyme wash

2

Wash

5

Rinse

2

Rinse

0.25

Water Detergent/ Temp Water Type Cold Tap N/A Water <40°C Neutral, Enzymatic (104°F) Cleaner 66°C Neutral pH (151°F) Detergent >40°C Tap water (104°F) Critical water Ambient (RO, deionized or distilled water)

Step 4: Thermal Disinfection

Thermal disinfection is recommended to render devices safe for handling prior to steam sterilization. Thermal disinfection should be conducted in a washer-disinfector compliant to ISO 15883-1 and -2, or to an equivalent standard. Thermal disinfection in the washer-disinfector shall be validated to provide an A0 of at least 600 (e.g., 90°C (194°F) for 1 minute). Higher levels of A0 can be achieved

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by increasing the exposure time and temperature (e.g., A0 of 3000 at >90°C (194°F) for 5 minutes, in accordance with local requirements). Load the device components in the washerdisinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens can drain freely. Lumened devices should be placed in a vertical position. If this is not possible due to space limitations within the washer-disinfector, use an irrigating rack /load carrier with connections designed to ensure an adequate flow of process fluids to the lumen or cannulation of the device if provided. The following automated cycles are examples of validated cycles: Recirculation Water Phase Time (minutes) Temp Water Type Critical water Thermal >90°C 1 (RO, deionized or Disinfection (194°F) distilled water) Critical water Thermal >90°C 5 (RO, deionized or Disinfection (194°F) distilled water)

Step 5: Drying

It is recommended that drying is conducted in a washerdisinfector compliant to ISO 15883-1 and -2, or to an equivalent standard. Drying efficiency in washer-disinfectors can range considerably based on the automated system design and load configuration. The following automated cycle is an example of a validated cycle: Recirculation Phase Time (minutes) Air Temp Air Type Dry 7 115°C (239°F) Medical grade Following automated drying, inspect the device for residual moisture. Any residual moisture identified should be dried manually (as described below).

For manual drying:

• Ensure each device is dried and inspected thoroughly. • For external surfaces, use a clean, soft, lint-free cloth to avoid damage to the surface. • Open and close or actuate any applicable devices with moving parts during drying. Pay special attention to any device threads, ratchets and hinges or areas where fluid can accumulate. Clean, compressed air (e.g., medical grade) may be used to facilitate surface drying. • Dry all lumen/cannulated parts using clean compressed air (e.g., medical grade).

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Step 6: Maintenance and Inspection

Instruments should be visually inspected under ambient lighting, to verify that the devices do not have visible soil, damage or moisture.

Inspect devices for:

• Lack of moisture. Carefully inspect device lumens and moving parts. If moisture is detected, manually drying should be performed. • Cleanliness. If any residual soil is discovered during inspection, repeat the cleaning steps on those devices until all visible soil is removed from the device. • Damage, including but not limited to, corrosion (rust, pitting), discoloration, excessive scratches, flaking, cracks and wear. • Proper function, including but not limited to, sharpness of cutting tools, bending of flexible devices, movement of hinges/joints/box locks and moveable features such as handles, ratcheting and couplings and missing or removed part numbers. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and worn devices should be discarded. Disassembled devices should be reassembled prior to sterilization when specified. Lubricate any moving parts with a water-soluble surgical instrument lubricant. The lubricant should be approved for use on medical devices and provided with data to ensure biocompatibility and compatibility with steam sterilization.

Step 7: Packaging

Place cleaned, dry devices into the specified locations within the cases provided, if applicable. Only legally marketed, and locally approved sterilization barriers (e.g., wraps, pouches or containers) should be used for packaging terminally sterilized devices, in compliance with the manufacturer’s instructions.

Step 8: Sterilization

Steam (moist heat) sterilization shall be performed in a locally approved, pre-vacuum (forced air removal) cycle. The steam sterilizer should be validated to the requirements of any local standards and guidance such as EN 285 or AAMI/ANSI ST8. The steam sterilizer should be installed and maintained in compliance with manufacturer’s instructions and local requirements. Ensure that the steam sterilizer cycle that is chosen is designed to remove air from porous or lumened device loads in accordance with manufacturer’s instructions and does not exceed the criteria for sterilizer load.

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The following steam sterilization cycles are examples of validated cycles: Minimum Sterilization Minimum Exposure Sterilization Conditioning Time Exposure Phase (minutes) Temperature Dry Time* 30-60 Pre-vacuum 4 132°C (270°F) minutes 30-60 Pre-vacuum 3 134°C (274°F) minutes Extended steam exposure cycle can be used to meet local requirements such as 134°C (274°F) for 18 minutes. * When applying dry times to DePuy Synthes cases and their accessories, dry times outside the standard healthcare pre-vacuum parameters may be required. This is especially important for polymer-based (plastic) cases/trays used in conjunction with heavy duty nonwoven sterilization wraps. The current recommended dry times for DePuy Synthes cases can range from a standard 30 minutes to an extended time of 60 minutes. The dry time is most often influenced by the presence of polymer based (plastic) materials; therefore, changes such as elimination of silicone mats and/or change in sterile barrier system (e.g., heavy grade to light grade wrap or the use of rigid sterilization containers) can reduce the necessary dry time. Dry times may be highly variable due to differences in packaging materials (e.g., nonwoven wraps), environmental conditions, steam quality, device materials, total mass, sterilizer performance and varying cool down time. The user should employ verifiable methods (e.g., visual inspections) to confirm adequate drying. Do not exceed 140°C (284°F) during drying. Immediate-Use steam sterilization is only intended for individual instruments and should only be performed when approved by local policies. DePuy Synthes does not support immediate-use steam sterilization of instrument sets, cases or implants using this method. The following steam sterilization cycle is an example of a validated cycle for individual instruments only: • Unwrapped instrument • A minimum 3 (three) pulse pre-vacuum cycle • 132°C (270°F) for 4 minutes

Step 9: Storage

Sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Refer to sterilization wrap or rigid container manufacturers IFU for limits on sterile product storage time and storage requirements for temperature and humidity.

Additional Information

Cleaning agent information: Examples of detergents that have been used during cleaning validations include Prolystica™ 2X Concentrate Enzymatic Cleaner, Prolystica™ 2X Neutral Detergent, Enzol™, Endozime™, Neodisher Medizym™, Tergazyme™, and NpH-Klenz™. Further information regarding the use of specific cleaning agents, ultrasonic washers, washer-disinfector, packaging materials or sterilizers during validation studies are available on request. The chemical quality of the water used during reprocessing can impact device safety. Facilities should use the recommended water quality requirements for device reprocessing in accordance with local guidance (such as AAMI TIR 34, Water for the reprocessing of medical devices) and these instructions for use. These instructions for use have been validated in accordance with ISO 17664. It remains the responsibility of the facility to ensure that the processing is performed using equipment, materials and personnel at a designated area, and achieves the desired requirements. This includes validation and routine monitoring of the process. Likewise, any deviation by the processor from these recommendations should be evaluated for effectiveness and any potential adverse consequences. All personnel using these instructions should be qualified with documented expertise, competency and training. Users should be trained on healthcare facility policies and procedures along with current applicable guidelines and standards.

MATERIALS Material:

Standard(s):

302 Stainless Steel

ASTM F899 / A564

302HQ Stainless Steel

ASTM A240 / A276

303 Stainless Steel

ASTM F899 / A564

304 Stainless Steel

ASTM A240 / A276

304-2B Stainless Steel

ASTM A240 / A276

305 Stainless Steel

ASTM A240 / A276

316 Stainless Steel

ASTM F899 / A313

420 Stainless Steel

ASTM F899 / A564

440C Stainless Steel

ASTM F899 / A276

455 Stainless Steel

ASTM F899 / A564

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Material:

Standard(s):

465 Stainless Steel

ASTM F899 / A564

17-4 PH Stainless Steel

ASTM F899 / A564

17-7 PH Stainless Steel

ASTM F899 / A564

18-8 Stainless Steel

ASTM F593 / F899 / A564

5052-H32 AL

ASTM B209

6061-T6 AL

ASTM B211 / B221

7075-T6 Al

ASTM B211 / B221

TiAlN

AMS 2444

Nitinol

ASTM F2063

Nylon Coating

ANSI/AWWA C22401

Silicone

USP CLASS VI

Silicone Rubber

ASTM D2000

Radel

ASTM D6394

Homopolymer Polypropylene (HPP) ASTM D4101

SUMMARY OF SAFETY AND CLINICAL PERFORMANCE

A summary of safety and clinical performance can be found in the European Medical Device Database (EUDAMED). Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and /or patient is established.

LIMITED WARRANTY AND DISCLAIMER

PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS, ARE HEREBY DISCLAIMED. IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF THIS INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE FOR CURRENT INFORMATION AT +1-508-880-8100.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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SYMBOL TRANSLATION

MR Safe PACKAGING UNIT

DO NOT USE IF PACKAGE IS DAMAGED

DO NOT RESTERILIZE

MATERIAL MATERIAL

T2

CAUTION MR Unsafe SINGLE USE

T1

MEDICAL DEVICE

CONSULT INSTRUCTIONS FOR USE

Lower Limit of temperature = T1 Upper Limit of temperature = T2

LOT LOT NUMBER SN SERIAL NUMBER

STERILE A Contains EU Regulated Sterile medical device Medicinal Substance processed using aseptic technique

STORE AT ROOM TEMPERATURE

QTY QUANTITY SZ SIZE

STERILE R STERILIZATION BY IRRADIATION

MADE IN MADE IN

KEEP AWAY FROM SUNLIGHT

NTI NEURAL TISSUE INSTRUMENT IOM NEUROMONITORING INSTRUMENTS

ATTENTION. SEE INSTRUCTIONS FOR USE

Contains EU Regulated Chemical Substance

STERILE EO STERILIZATION BY ETHYLENE OXIDE STERILE GP STERILE GAS PLASMA

Contains Human Blood product

PACKAGE CONTAINS FLAMMABLE LIQUID

NON STERILE

LATEX FREE LATEX FREE

NONSTERILE NONSTERILE

DATE OF MANUFACTURE

MANUFACTURE AND DATE OF MANUFACTURE EC REP AUTHORIZED EUROPEAN REPRESENTATIVE DIST DISTRIBUTED BY

STERILE Sterilized using steam or dry heat

MSR MEASURING DEVICE Federal (USA) law restricts this device to sale by or on the order of a physician

MANUFACTURER

STERILE STERILE

25°C

REF REF CATALOG NUMBER

MR Conditional

Contains Human Origin Substance

Contains Animal Origin Substance

UDI UNIQUE DEVICE IDENTIFICATION XXXX-XX USE BY

STERILE BARRIER SYSTEM

MATERIAL ACROFLEX®/Ti

A/T ACROFLEX®/Titanium

P/F PL/FOAM Plastic/Foam

A AI Aluminum

PY Polyester

A/P Al/PL Aluminum/Plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer

SRSI SS/RADEL®/SILICONE Stainless Steel/RADEL® / Silicone SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Stainless Steel/RADEL® / Silicone/Titanium Aluminum Nitride

Ti/HA Titanium/Hydroxyapatite Ti/UHMWPE/HA Titanium/Ultra-High Molecular Weight Polyethylene/Hydroxyapatite SS/Ti Stainless Steel/Titanium

PEEK OPTIMA® Polyether Ether Ketone

SS/Al/SILICONE SS/RADEL®/ SILICONE/Ti Nitride Stainless Steel/ ®/ Stainless Steel/RADEL Aluminum/Silicone P POLYMER This document is valid only on the date printed. If unsure of the print date, please Silicone/Titanium Nitride CaP Polymer SS/SILICA GLASS 2021-06-07 17:35:05 re-print to ensure use of the latest revision of the IFU SRTA (available at www.e-ifu.com). CALCIUM PHOSPHATE Stainless Steel/Silica Glass P/CMthe user PE/CoCrMo The onus resides with to ensure thatSS/RADEL the most®up-to-date Calcium Phosphate /Ti Al NitrideIFU is used. Polyethylene/Cobalt Stainless Steel/RADEL® / SS/SILICA GLASS/ CM CoCrMo Chromium Molybdenum

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MATERIAL A/T ACROFLEX®/Ti ACROFLEX®/Titanium

P/F PL/FOAM Plastic/Foam

A AI Aluminum

PY Polyester

A/P Al/PL Aluminum/Plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer CaP CALCIUM PHOSPHATE Calcium Phosphate CM CoCrMo Cobalt Chromium Molybdenum CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Cobalt Chromium Molybdenum/Titanium/ Calcium Phosphate CoNiCrMo Cobalt Nickel Chromium Molybdenum F

FOAM Foam

PEEK OPTIMA® Polyether Ether Ketone P

POLYMER Polymer

P/CM PE/CoCrMo Polyethylene/Cobalt Chromium Molybdenum P/C POLYMER/CARBON FIBER COMPOSITE Polymer/ Carbon Fiber Composite Si/NITINOL Silicone/Nitinol S SS Stainless Steel S/A SS/Al Stainless Steel/Aluminum

HA Hydroxyapatite

SBR Stainless Steel/Barium/ RADEL®

NiTi Ni/Ti Nickel/Titanium

S/P SS/PHENOLIC Stainless Steel/Phenolic

PL Plastic

S/PL SS/PL Stainless Steel/Plastic

2021-06-07 17:35:05

SS/Ba/RADEL®

SRSI SS/RADEL®/SILICONE Stainless Steel/RADEL® / Silicone SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Stainless Steel/RADEL® / Silicone/Titanium Aluminum Nitride SS/RADEL®/ SILICONE/Ti Nitride Stainless Steel/RADEL®/ Silicone/Titanium Nitride SRTA SS/RADEL®/Ti Al Nitride Stainless Steel/RADEL® / Titanium Aluminum Nitride STA SS/Ti Al Nitride Stainless Steel/ Titanium Aluminum Nitride S/U SS/ULTEM Stainless Steel/Ultem T Ti Titanium and its alloys S/R SS/RADEL® Stainless Steel/RADEL® R/T POLYOLEFIN RUBBER/Ti Polyolefin Rubber/Titanium T/A Ti/Al Titanium/Aluminum Ti/CoCrMo Titanium/Cobalt Chromium Molybdenum

Ti/HA Titanium/Hydroxyapatite Ti/UHMWPE/HA Titanium/Ultra-High Molecular Weight Polyethylene/Hydroxyapatite SS/Ti Stainless Steel/Titanium SS/Al/SILICONE Stainless Steel/ Aluminum/Silicone SS/SILICA GLASS Stainless Steel/Silica Glass SS/SILICA GLASS/ PL/SILICONE Stainless Steel/Silica Glass/ Plastic /Silicone SS/SILICA GLASS/ RADEL® /SILICONE Stainless Steel/Silica Glass/ RADEL® /Silicone SS/SILICA GLASS/ SILICONE Stainless Steel/ Silica Glass/Silicone S/SI SS/SILICONE Stainless Steel/Silicone SS/WC/SILICONE Stainless Steel/Tungsten Carbide/Silicone W/C Tungsten Carbide

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Medos International SÀRL Chemin-Blanc 38 2400 Le Locle, Switzerland

EC REP DePuyIreland Ireland UC UC DePuy Loughbeg, Ringaskiddy Loughbeg, Ringaskiddy Co. Cork, Ireland Co. Cork, Ireland Tel: +353 214914000 Fax: +353 214914199

Issued 2021/04 © DePuy Synthes 2021. All rights reserved. 2021-06-07 17:35:05

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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MATERIAAL A/T ACROFLEX®/Ti ACROFLEX®/titanium

P/F PL/FOAM Plastic/schuim

S/PL SS/PL Roestvrij staal/plastic

A AI Aluminium

PY Polyester

A/P Al/PL Aluminium/plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyetheretherketon/ koolstofvezelcomposiet

SRSI SS/RADEL®/SILICONE Roestvrij staal/ RADEL® /silicone

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Bariumsulfaat (BaSO4)/ PEEK-polymeer CaP CALCIUM PHOSPHATE Calciumfosfaat CM CoCrMo Kobaltchroommolybdeen CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Kobaltchroommolybdeen/ titanium/calciumfosfaat

PEEK OPTIMA® Polyetheretherketon P

POLYMER Polymeer

P/CM PE/CoCrMo Polyethyleen/ kobaltchroommolybdeen P/C POLYMER/CARBON FIBER COMPOSITE Polymeer/ koolstofvezelcomposiet

SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Roestvrij staal/ RADEL®/silicone/ titanium-aluminiumnitride SS/RADEL®/ SILICONE/Ti Nitride Roestvrij staal/RADEL®/ silicone/titaniumnitride SRTA SS/RADEL®/Ti Al Nitride Roestvrij staal/RADEL® / titanium-aluminiumnitride STA SS/Ti Al Nitride Roestvrij staal/ titanium-aluminiumnitride

Ti/CoCrMo Titanium/ kobaltchroommolybdeen Ti/HA Titanium/hydroxyapatiet Ti/UHMWPE/HA Titanium/polyethyleen met ultrahoog molecuulgewicht/ hydroxyapatiet SS/Ti Roestvrij staal/titanium SS/Al/SILICONE Roestvrij staal/ aluminium/silicone SS/SILICA GLASS Roestvrij staal/silicaglas SS/SILICA GLASS/ PL/SILICONE Roestvrij staal /silicaglas/ plastic/silicone SS/SILICA GLASS/ RADEL® /SILICONE Roestvrij staal/silicaglas/ RADEL®/silicone

Si/NITINOL Silicone/nitinol

S/U SS/ULTEM Roestvrij staal/Ultem

S SS Roestvrij staal

T Ti Titanium en zijn legeringen

S/A SS/Al Roestvrij staal/aluminium

SS/SILICA GLASS/ SILICONE Roestvrij staal/silicaglas/ silicone

S/R SS/RADEL® Roestvrij staal/RADEL®

S/SI SS/SILICONE Roestvrij staal/silicone

NiTi Ni/Ti Nikkel/titanium

SBR SS/Ba/RADEL® Roestvrij staal/barium/ RADEL®

R/T POLYOLEFIN RUBBER/Ti Polyolefinerubber/titanium

SS/WC/SILICONE Roestvrij staal/ wolfraamcarbide/silicone

PL Plastic

S/P SS/PHENOLIC Roestvrij staal/fenol

T/A Ti/Al Titanium/aluminium

W/C Wolfraamcarbide

CoNiCrMo Kobaltnikkelchroommolybdeen F

FOAM Schuim

HA Hydroxyapatiet

2021-06-07 17:35:05

Dit document is alleen geldig op de afgedrukte datum. Maak opnieuw een afdruk als de afgedrukte datum niet duidelijk is, zodat u zeker weet dat u de laatste revisie van de gebruiksaanwijzing gebruikt (beschikbaar op www.e-ifu.com). Het is de verantwoordelijkheid van de gebruiker dat gebruik wordt gemaakt van de meest recente gebruiksaanwijzing.

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