HIP AND KNEE REVISION Systems Instructions for Use and Reprocessing

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INSTRUCTION FOR USE AND REPROCESSING FOR HIP AND KNEE REVISION SYSTEMS

These instructions are in accordance with ISO 17664 and AAMI ST81. They apply to: • Reusable surgical instruments and accessories (provided as non-sterile and sterile STERILE ) supplied by Tecomet and intended for reprocessing in a health care facility setting. All instruments and accessories may be safely and effectively reprocessed using the manual or combination manual/automated cleaning instructions and sterilization parameters provided in this document UNLESS otherwise noted in instructions accompanying a specific instrument. • Non-sterile single use instruments. • Sterile STERILE single use instruments. NON STERILE

NON STERILE

In countries where reprocessing requirements are more stringent than those provided in this document it is the responsibility of the user/processor to comply with those prevailing laws and ordinances.

These reprocessing instructions have been validated as being capable of preparing instruments and accessories for surgical use. It is the responsibility of the user/hospital/health care provider to ensure that reprocessing is performed using the appropriate equipment, materials and that personnel have been adequately trained in order to achieve the desired result; this normally requires that equipment and processes are validated and routinely monitored. Any deviation by the user/hospital/ health care provider from these instructions should be evaluated for effectiveness to avoid potential adverse consequences. Intended Use Hip Revision System The Hip Revision System is specifically used to aid in the extraction of all Total Hip Arthroplasty (THA) implant components and bone cement. These instruments may also be used to shape the remaining bone in preparation to receive a new implant during a revision procedure.

Knee Revision System The Knee Revision System is a set of medical instruments used in the removal and replacement of knee implants. This set of instruments is specifically used to aid in the extraction of all Total Knee Arthroplasty (TKA) implant components and bone cement. These instruments may also be used to shape the remaining bone in preparation to receive a new implant.

Intended Patient Population Hip Revision System The device is prescriptive, therefore, a knowledgeable orthopedic surgeon may utilize this set of instruments on any patient he or she deems applicable. The device is to be used on patients undergoing a procedure that requires the removal and replacement of hip implants. Knee Revision System The device is prescriptive, therefore, a knowledgeable orthopedic surgeon may utilize this set of instruments on any patient he or she deems applicable. The device is to be used on patients undergoing a procedure that requires the removal and replacement of knee implants.

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Indications For Use Hip Revision System The device is to be used on patients undergoing a procedure that requires the removal and replacement of hip implants. Knee Revision System The device is to be used on patients undergoing a procedure that requires the removal and replacement of knee implants. Contra-indications There are no specific contra-indications for the subject devices. They are handheld instruments used at the discretion of the operating surgeon.

Intended User The Hip and Knee Revision Systems are prescriptive and therefore to be used by qualified orthopedic surgeons trained in the respective surgical technique. Expected Clinical Benefits When used as intended, the Hip and Knee Revision Systems aid in the safe removal of the previously failed implant.

Performance Characteristics The Hip and Knee Revision Systems aid in the safe removal of the previously failed implant Adverse Events & Complications All surgical operations carry risk. The following are frequently encountered adverse events and complications related to having a surgical procedure in general: • Delay to surgery caused by missing, damaged or worn instruments. • Tissue injury and additional bone removal due to blunt, damaged or incorrectly positioned instruments. • Infection and toxicity due to improper processing. Adverse events to user: • Cuts, abrasions, contusions or other tissue injury caused by burs, sharp edges, impaction, vibration or jamming of instruments.

Adverse Events & Complications – Reporting of Serious Incidents Serious Incident Reporting (EU)

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. Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: • The death of a patient, user, or other person, • The temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, • A serious public health threat.

Warnings and Limitations Warnings •

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U.S Federal law restricts this device to sale by or on the order of a physician. ONLY

• Instruments that are labeled single use are intended to be used one time and then discarded. • Risks of reusing single use instruments include but are not limited to infection to the patient and/or reduced reliability of function. • Reprocessing instructions do not apply to Sterile STERILE instruments. single use • Sterile STERILE - single use instruments are intended to be used one time then discarded. • Sterile STERILE instruments in visibly damaged sterile STERILE packaging should be discarded. • Reusable instruments and accessories that are provided NONSTERILE must be cleaned and sterilized according to these instructions prior to each use. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated instruments and accessories. • If present, safety caps and other protective packaging material must be removed from the instruments prior to the first cleaning and sterilization. • Caution should be exercised while handling, cleaning, or wiping instruments and accessories with sharp cutting edges, tips, and teeth. • Ethylene oxide (EO), gas plasma and dry heat sterilization methods are not recommended for sterilization of reusable instruments. Steam (moist heat) is the recommended method. • Saline and cleaning/disinfection agents containing aldehyde, chloride, active chlorine, bromine, bromide, iodine or iodide are corrosive and should not be used. • Do not allow biologic soil to dry on contaminated devices. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluids and tissue debris to dry on used instruments. • Automated cleaning using a washer/disinfector alone may not be effective for instruments with lumens, blind holes, cannulas, mated surfaces and other complex features. A thorough manual cleaning of such device features is recommended before any automated cleaning process. • Metal brushes and scouring pads must not be used during manual cleaning. These materials will damage the surface and finish of the instruments. Use only soft bristle nylon brushes with different shapes, lengths and sizes to aid with manual cleaning. • When processing instruments do not place heavy devices on top of delicate instruments. • Use of hard water should be avoided. Softened tap water may be used for most rinsing however purified water should be used for final rinsing to prevent mineral deposits. • Do not process instruments with polymer components at temperatures equal to or greater than 140°C/284°F because severe surface damage to the polymer will occur. • Silicone lubricants should not be used on surgical instruments. • As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument during use. Excessive force can result in instrument failure. • Orthopedic instruments should not be utilized on internal organs, vascular structures, or nervous system structures. • The delivery systems are not intended to maintain sterility by themselves. They are designed to facilitate the sterilization process when used with an FDA approved sterilization wrap. Wrapping material is designed to allow air removal, steam penetration/evacuation (drying) and to maintain the sterility of the internal components. NON STERILE

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• Ensure firm connection with the assembled device prior to use.

Materials and Restricted Substance • For indication that the device contains a restricted substance or material of animal origin see product label.

Device Life • The life expectancy of a reusable instrument and its accessories are dependent on the frequency of use and the care and maintenance the instruments receive. However, even with proper handling as well as correct care and maintenance, reusable instruments and accessories should not be expected to last indefinitely. Therefore, an accurate estimate of end of life is not possible for these types of manual, reusable devices. • Instruments and accessories should be inspected for damage and wear before each use. Instruments and accessories that show signs of damage or excessive wear should not be used. • Due to the high wear nature of cutting and reaming instruments, the device life of these types of devices is 1 year. These devices should be inspected before each use for wear and degradation. • Single use instruments are intended to be used one time and then discarded. Disposal • At the end of the device’s life safely dispose of the device in accordance with local procedures and guidelines. • Any device that has been contaminated with potentially infectious substances of human origin (such as bodily fluids) should be handled according to hospital protocol for infectious medical waste. Any device that contains sharp edges should be discarded according to hospital protocol in the appropriate sharps container.

Limitations on Reprocessing • Repeated processing according to these instructions has minimal effect upon metal reusable instruments and accessories unless otherwise noted. End of life for stainless steel or other metal surgical instruments is generally determined by wear and damage incurred during the intended surgical use. • Instruments comprised of polymers or incorporating polymer components can be sterilized using steam however they are not as durable as their metal counterparts. If polymer surfaces show signs of excessive surface damage (e.g. crazing, cracks or delamination), distortion or are visibly warped they should be replaced. Contact your Tecomet representative for your replacement needs. • Instruments with removable polymer sleeves or components must be disassembled for sterilization (e.g. acetabular reamer drivers with tissue protector sleeve). • Non-foaming, neutral pH enzymatic and cleaning agents are recommended for processing reusable instruments and accessories. • Alkaline agents with a pH of 12 or less may be used to clean stainless steel and polymer instruments in countries where required by law or local ordinance; or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeld-Jakob Disease (CJD) are a concern. It is critical that alkaline cleaning agents are completely and thoroughly neutralized and rinsed from the devices or degradation may occur that limits the device life. • The delivery systems have NOT been validated for use with flexible endoscopes, or devices with lumens or working 4

channels longer than 4 inches (3mm ID). Always refer to instrument manufacturer instructions. • The delivery systems have NOT been validated for ETO sterilization of devices. • Tecomet delivery systems have not been validated for use in filtered sterilization containers and Tecomet does not recommend use of such a system. If filtered sterilization container systems are used, the user is responsible for following the recommendations of the manufacturer for the proper placement and use of cases and trays inside the container.

Reprocessing Instructions

Point of Use • Remove excess biologic soil from the instruments with a disposable wipe. Place devices in a container of distilled water or cover with damp towels. Note: Soaking in proteolytic enzyme solution prepared according to the manufacturer will facilitate cleaning especially in instruments with complex features such as lumens, mating surfaces, blind holes and cannulas. • If instruments cannot be soaked or maintained damp then they should be cleaned as soon as possible after use to minimize the potential for drying prior to cleaning. Containment and Transportation • Used instruments must be transported to the decontamination area for reprocessing in closed or covered containers to prevent unnecessary contamination risk.

Cleaning • It is highly recommended that as soon as possible after each surgical procedure, and before sterilization, the instruments be cleaned in order to limit the drying time of residue biologic soil left on the instruments. • Water quality used for diluting cleaning agents and for rinsing instruments should be carefully considered. Use of distilled water for cleaning and sterile water for rinsing is recommended. Avoid using hot water as this will coagulate and harden protein based soil. • All cleaning agents and disinfectants must be prepared according to the recommendations of their manufacturer. Only use cleaning agents and disinfectants that have a nearly neutral pH and are approved for use on surgical instruments.

Point of Use Pre-cleaning • Remove excess biologic soil and tissue from instruments using disposable wipes. • As soon as possible after use, set instruments in a basin of distilled water or in a tray covered with damp towels. Manual Cleaning of Instruments 1. Prepare a proteolytic enzyme based detergent like Enzol (or equivalent) and prepare a cleaning solution according to the detergent manufacturer’s recommendation. 2. Immerse instruments and soak for the time recommended by the detergent manufacturer. • While immersed actuate all hinged devices and those with moving parts. 3. Use a soft bristle cleaning brush and scrub the instruments until all visible contamination has been removed. Scrub the

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device below the surface of the cleaning solution to prevent aerosolization of contaminants. Pay particular attention to the features that will pose a challenge to effective cleaning. Follow these general guidelines: • Using the brush, scrub all surfaces of the device. Pay particular attention to any cutting features or rough surfaces used for filing or abrading. • Use a snug fitting pipe cleaner to access blind holes or cannula. Insert and rotate in blind holes or pass the pipe cleaner through any cannula three (3) times. 4. Rinse thoroughly with distilled water until all traces of cleaning solution are removed. • Actuate all hinged devices and those with moving parts while rinsing. 5. Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature recommended by the detergent manufacturer. 6. Submerge the instruments and activate the bath for a minimum of 10 minutes. A frequency of 25 – 50 kHz is recommended. 7. Remove and rinse the instruments in distilled or sterile water for at least one (1) minute or until all traces of cleaning solution are removed. • Actuate all hinged devices and those with moving parts while rinsing. 8. Visually inspect the instruments for visible soil and repeat these cleaning steps if remaining soil is observed. 9. Dry the instruments with clean, lint-free wipes in preparation for sterilization. Use clean pressurized air to remove moisture from hard to reach areas. Automated Cleaning of Instruments Using Washer-Disinfector 1. Prepare a solution of enzymatic detergent according to the manufacturer’s recommendations. 2. Immerse instruments and soak for the time recommended by the detergent manufacturer. • While immersed actuate all hinged devices and those with moving parts. 3. Use a soft bristle cleaning brush and scrub the instruments until all visible contamination has been removed. Scrub the device below the surface of the cleaning solution to prevent aerosolization of contaminants. Pay particular attention to the features that will pose a challenge to effective cleaning. Follow these general guidelines: • Using the brush scrub all surfaces of the device. Pay particular attention to any cutting features or rough surfaces used for filing or abrading. • Use a snug fitting pipe cleaner to access blind holes or cannula. Insert and rotate in blind holes or pass the pipe cleaner through any cannula three (3) times. 4. Rinse thoroughly with distilled water until all traces of cleaning solution are removed. • Actuate all hinged devices and those with moving parts while rinsing. 5. Load instruments in an automated washer-disinfector in a manner that maximizes exposure of the instrument surfaces. 6. Operate the washer-disinfector according to the manufacturer’s instructions to ensure all cycle parameters (i.e. time, temperature) are followed. 7. Remove instruments and check for remaining soil or wetness. If soil remnants are observed repeat the automated cleaning cycle. If remaining wetness is observed dry the instruments with clean, lint-free wipes in preparation for sterilization. 6

Manual Cleaning of Sterilization Container 1. Prepare a solution of neutral pH detergent according to the manufacturer’s recommendations. Cleansers that are too acidic or alkaline may damage the anodized finish of the aluminum case. 2. Using a soft sponge or cloth, clean all surfaces of the container base, lid and instrument trays. 3. Thoroughly rinse the container components under clean running water to remove all residue detergent. 4. Thoroughly dry the container components. Automated Cleaning of Sterilization Container Using WasherDisinfector 1. Prepare a solution of neutral pH detergent according to the washer manufacturer’s recommendations. 2. Place the container components into the washer in a manner that will prevent them from moving and start the cycle. 3. After the cleaning cycle is complete remove the container components and verify they are dry. If wetness is observed, dry the components with clean, lint-free wipes.

Lubrication • After cleaning and before sterilization, instruments with moving parts (e.g. hinges, box-locks, sliding or rotating parts) should be lubricated with a water-soluble lubricant such as Preserve®, Instrument Milk or equivalent material intended for medical device application. Always follow the lubricant manufacturer’s instructions for dilution, shelf life and application method. Sterilization • Moist heat/steam sterilization is the preferred and recommended method for the instrument set. • The instruments and container must be properly cleaned before sterilization. • Place the instruments in their respective position within the sterilization container according to the markings / labeling in the container. Once the container is loaded put the lid on and secure all lid locks. The closed container should now be wrapped with an approved wrap according to the AAMI ST79 recommendations. The container is now ready for sterilization according to the parameters listed below. Recommended Parameters for Steam Sterilization

Sterilization Mode

Exposure Temp. Exposure Time

*Dry Time

Dynamic-AirRemoval

132°C (270°F)

60 minutes

Dynamic-AirRemoval

135°C (275°F)

4 minutes 3 minutes

60 minutes

* Fully loaded cases validated with 60 minutes cooling time using two applications of Kimguard KC600 single ply wrap using sequential envelope technique per AAMI ST79. The drying time may vary due to sterilization equipment used, wrapping method, and material. It is the health care facility’s responsibility to validate the appropriate drying time using their process.

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Storage • Sterile STERILE packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin and temperature/humidity extremes. Note: Inspect every package before use to ensure that the sterile barrier (e.g. wrap, pouch or filter) is not torn, perforated, shows signs of moisture or appears to be tampered with. If any of those conditions are present then the contents are considered non-sterile and should be re-processed through cleaning, packaging and sterilization.

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Symbols Used on Labeling: Caution NON STERILE

STERILE

ONLY

2797 2797 EC

REP

Non-Sterile Sterile

U.S Federal law restricts this device to sale by or on the order of a physician CE Mark1

CE Mark with Notified Body #1

Authorized Representative in the European Community Manufacturer

Date of Manufacture REF

Lot Number

Catalog Number

Consult Instructions for Use Single Use; Do Not Reuse STERILE R



Distributor

Sterilized by irradiation Medical Device Packaging Unit

Country of Manufacture

Do not use if package is damaged and consult instructions for use CH REP

Use by

Swiss Authorized Representative2 Importer

Unique Device Identifier

Refer to the labeling for CE information Refer to the labeling for Swiss Authorized Representative

1 2

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Additional Labeling: “MANUAL USE ONLY”

“REMOVE FOR CLEANING & STERILIZATION”

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Device should not be attached to a power source and is only intended to be handled manually.

Device should be disassembled prior to cleaning and sterilization.

Manufactured By:

EC

2797 2797

Legal Name:

Symmetry Medical Manufacturing Inc. 486 West 350 North Warsaw, IN 46582 USA Phone: +1 574 267 8700 www.tecomet.com CH REP

European Representative: Symmetry Medical Polyvac S.A.S Parc d’Activités du Moulin 139, Avenue Clément Ader Wambrechies 59118 France Phone: +33 3 28 09 94 54

MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland Distributed by:

DePuy Orthopaedics, Inc 700 Orthopaedic Drive Warsaw, IN 46582 Tel: 1 + (800) 366 8143 Importer: Depuy Ireland UC Loughbeg, Ringaskiddy Co. Cork, Ireland

7012-99 Rev H (06/16/2022)

REP