GLOBAL UNITE Short Stem Instrumentation Instructions for Use and Reprocessing

English - EN

GLOBAL UNITE™ Short Stem Instrumentation Instructions for Use and Reprocessing These instructions are in accordance with ISO 17664 and AAMI ST81. They apply to: • Reusable instruments in the GLOBAL UNITE™ Short Stem (GUSS) instrument set (provided as non-sterile) distributed by DePuy-Synthes that are intended for usage and 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. • Reusable delivery system (case, tray, and lid) that holds the GUSS instrument set for protection, organization, steam sterilization and delivery to the surgical field. • Some products may not be licensed in all jurisdictions. NON STERILE

INSTRUCTIONS FOR USE

Materials & restricted substances For indication that the device contains a restricted substance or material of animal origin see product label.

Description The GUSS instrumentation set is a set of medical instruments used during shoulder arthroplasty. This set of devices is used to prepare the humerus during anatomical or reverse shoulder replacements. The instruments are reusable and can be re-sterilized using standard methods available to hospitals and orthopedic care centers. Intended Use The GUSS instrumentation set is a set of medical instruments used during shoulder arthroplasty. This set of devices is used to prepare the humerus during anatomical or reverse shoulder replacements. The instruments aid in reaming, broaching, and aligning the reaming of the humerus during surgery.

1

Delivery systems (cases, trays, and lids) are intended for the protection and organization of the instruments during the sterilization and delivery to the surgical field. The delivery systems (cases and trays) are not designed to maintain sterility by themselves. They are designed to facilitate the sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation (drying) and maintain the sterility of the internal components. Intended Patient Population The GUSS instrumentation set is prescriptive; therefore, a knowledgeable orthopedic surgeon may utilize the device on any patient he or she deems applicable. The device is to be used on patients undergoing a procedure that requires shoulder arthroplasty.

Indications for Use The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications. Contra-indications These orthopedic instruments are prescription use. The instruments are only to be used by qualified health care personnel. These instruments are not for use in other surgical approaches or on other anatomical locations.

Intended User The GUSS instrumentation set is prescriptive and therefore to be used by qualified orthopedic surgeons trained in the respective surgical techniques.

Accessories and/or other Device(s) intended to be used in combination with the product • The Proximal Reaming Guides are intended to be used with the Reamer Holder, Proximal Modular Reamer Adaptors, Modular Implant Sizer Disks, and Proximal Modular Reamers.2 • The Brosteotomes are intended to be used with the Implant Holder. They will also assemble to the Epiphyseal and Proximal Trial Components.2 • The Bullet Tip Reamers are intended to be used with the Ratchet T-Handle and the adjustable clamp of the Resection Guide.2 2

• The Wrench is intended to be used with the Brosteotomes and Implant Stems.2 Expected Clinical Benefits • When used as intended, the GUSS instrumentation set aids in the reaming, broaching, and aligning the reaming of the humerus during shoulder arthroplasty utilizing the Global Unite Shoulder System Short Humeral Stem. 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. Where further information is desired, please contact your local Tecomet sales representative. For instruments produced by another legal manufacturer, reference the manufacturer’s instructions for use.

2 For the combinations mentioned above, ensure firm connection prior to use.

3

Performance and Characteristics The GUSS instrumentation set aids in the reaming, broaching, and aligning the reaming of the humerus during shoulder arthroplasty utilizing the Global Unite Shoulder System Short Humeral Stem.

WARNINGS •

U.S. Federal law restricts this device to sale by or on the order of a physician. • Due to design specifications, the devices should not be used with any manufacturer’s implant systems other than those specified. • Reusable instruments and accessories that are provided must be cleaned and sterilized according to these non-sterile instructions prior to each use. • Personal Protective Equipment (PPE) should be worn when handling, working with or disposal of 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, wiping or disposal of 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. NON STERILE

4

• 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/285°F because severe surface damage to the polymer will occur. • Oils or 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. • Instrument utilization is determined by the user’s experience and training in surgical procedures. Do not use this instrument for any purpose outside the intended use of the device, as it may seriously affect the safety and function of the product. Device Life • The GUSS Instrument Set is composed of reusable instruments. Life expectancy is 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 should not be expected to last indefinitely. • Instruments should be inspected for damage and wear before each use. Instruments that show signs of damage or excessive wear should not be used. 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.

5

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 visible warping they should be replaced. Contact your DePuy-Synthes representative for your replacement needs. • 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. 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 reusable instruments and accessories for surgical use. WARNING 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. WARNING Any deviation by the user/hospital/health care provider from these instructions should be evaluated for effectiveness to avoid potential adverse consequences.

6

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. Preparation for Cleaning • Instruments designed to come apart must be disassembled prior to cleaning and sterilization. Disassembly, where necessary, is generally self-evident however for more complicated instruments instructions for use are provided and should be followed. Note: All recommended disassembly will be possible by hand. Never use tools to disassemble instruments beyond what is recommended. • All cleaning solutions should be prepared at the dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning solutions. Note: Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (turbid). Manual Cleaning Steps • Step 1: Prepare a proteolytic enzyme solution according to the manufacturer’s instructions. • Step 2: Completely submerge instruments in the enzyme solution and gently shake them to remove trapped bubbles. Actuate instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes, and cannulations should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces.

7

• Step 3: Soak instruments for a minimum of 10 minutes. While soaking, scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs. Lumens, blind holes, and cannulas should be cleaned using a snug fitting round nylon bristle brush. Insert the snug fitting round brush into the lumen, blind hole, or cannula with a twisting motion while pushing in and out multiple times. Note: All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution. • Step 4: Remove the instruments from the enzyme solution and rinse in tap water for a minimum of one (1) minute. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. • Step 5: Prepare an ultrasonic cleaning bath with detergent and de-gas according to the manufacturer’s recommendations. Completely submerge instruments in the cleaning solution and gently shake them to remove any trapped bubbles. Lumens, blind holes and cannulations should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. Sonically clean the instruments at the time, temperature and frequency recommended by the equipment manufacturer and optimal for the detergent used. A minimum of ten (10) minutes is recommended. Notes: • Separate stainless steel instruments from other metal instruments during ultrasonic cleaning to avoid electrolysis. • Fully open hinged instruments. • Use wire mesh baskets or trays designed for ultrasonic cleaners. • Regular monitoring of sonic cleaning performance by means of an ultrasonic activity detector, aluminum foil test, TOSI™ or SonoCheck™ is recommended.

8

• Step 6: Remove the instruments from the ultrasonic bath and rinse in purified water for a minimum of one (1) minute or until there is no sign of residue detergent or biologic soil. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. • Step 7: Dry instruments with a clean, absorbent non-shedding lint free cloth. Clean, filtered compressed air may be used to remove moisture from lumens, holes, cannulas, and difficult to access areas. Combination Manual/ Automated Cleaning Steps • Step 1: Prepare a proteolytic enzyme solution according to the manufacturer’s instructions. • Step 2: Completely submerge instruments in the enzyme solution and gently shake them to remove trapped bubbles. Actuate instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes and cannulations should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. • Step 3: Soak instruments for a minimum of 10 minutes. Scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, roughened surfaces, and areas with moving components or springs. Lumens, blind holes and cannulas should be cleaned using a snug fitting round nylon bristle brush. Insert the snug fitting round nylon bristle brush into the lumen, blind hole or cannula with a twisting motion while pushing in and out multiple times. Note: All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution. • Step 4: Remove the instruments from the enzyme solution and rinse in tap water for a minimum of one (1) minute. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. • Step 5: Place instruments in a suitable validated washer/ disinfector. Follow the washer/disinfector manufacturer’s instructions for loading the instruments for maximum cleaning exposure; e.g. open all instruments, place concave instruments on their side or upside down, use baskets and trays designed for

9

washers, place heavier instruments on the bottom of trays and baskets. If the washer/disinfector is equipped with special racks (e.g. for cannulated instruments) use them according to the manufacturer’s instructions. • Step 6: Process instruments using a standard washer/ disinfector instrument cycle according to the manufacturer’s instructions. The following minimum wash cycle parameters are recommended:

Cycle

Description

1

Pre-wash • Cold Softened Tap Water • 2 minutes

3

Rinse • Cold Softened Tap Water

2 4 5 6

Enzyme Spray & Soak • Hot Softened Tap Water • 1 minute Detergent Wash • Hot Tap Water (64-66°C/146150°F) • 2 minutes

Rinse • Hot Purified Water (64-66°C/146-150°F) • 1 minute Hot Air Dry (116°C/240°F) • 7 – 30 minutes

Notes: • The washer/disinfector manufacturer’s instructions should be followed. • A washer/disinfector with demonstrated efficacy (e.g. FDA clearance or validated to ISO 15883) should be used. • Dry time is shown as a range because it is dependent upon the load size placed into the washer/disinfector. • Many manufacturers pre-program their washer/ disinfectors with standard cycles and they may include a thermal low-level disinfection rinse after the detergent wash. The thermal disinfection cycle should be performed to achieve a minimum value A0 = 600 (e.g. 90°C/194°F for 1 minute according to ISO 15883-1) and is compatible with the instruments. • If a lubrication cycle is available that applies to watersoluble lubricant such as Preserve®, Instrument Milk, or equivalent material intended for medical device 10

application it is acceptable to use on instruments unless otherwise indicated. Manual Cleaning Steps of Sterilization Container • Prepare a solution of neutral pH detergent according to the manufacturer’s recommendations. • Using a soft sponge or cloth, clean all surfaces of the container lid and instrument trays. • Thoroughly rinse the container components under clean running water to remove all residue detergent. • Thoroughly dry the container components. Automated Cleaning Steps of Sterilization Container • Prepare a solution of neutral pH detergent according to the washer manufacturer’s recommendations. • Place the container components into the washer in a manner that will prevent them from moving and start the cycle. • 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. Disinfection • Instruments must be terminally sterilized prior to use. See sterilization instructions below. • Low level disinfection may be used as part of a washer/ disinfector cycle but the devices must also be sterilized before use. Drying • Dry instruments with a clean, absorbent non-shedding lint free cloth. Clean, filtered compressed air may be used to remove moisture from lumens, holes, cannulas and difficult to access areas. Inspection & Testing • After cleaning, all devices should be thoroughly inspected for residue biologic soil or detergent. If contamination is still present repeat the cleaning process. • Visually inspect each device for completeness, damage, and excessive wear. If damage or wear is observed that might compromise the function of the device, do not process them further and contact your Tecomet representative for a replacement. 11

• When inspecting devices look for the following: • Cutting edges should be free of nicks and have a continuous edge. • Jaws and teeth should align properly. • Movable parts should operate smoothly throughout the intended range of motion. • Locking mechanisms should fasten securely and close easily. • Long thin instruments should be free of bending or distortion. • Where instruments form part of a larger assembly, check that all components are available and assemble readily. • Polymer surfaces should not show signs of excessive surface damage (e.g. crazing, cracks or delamination), distortion, or visible warping. If the instrument is damaged, it should be replaced. 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. Packaging for Sterilization • Instruments and container must be properly cleaned before sterilization. • Place the instruments in their respective position within the delivery system according to the markings/labeling in the container. • Once the container is loaded, put the lid on and secure all latches or locks. • Single devices may be packaged in an approved (e.g. FDA cleared or ISO 11607 compliant) medical grade sterilization pouch or wrap. Care should be used when packaging so that the pouch or wrap is not torn. Devices should be wrapped using the double wrap or equivalent method (ref: AAMI ST79, AORN Guidelines). • Reusable wraps are not recommended. • The case or tray must be wrapped in an approved (e.g. FDA cleared or ISO 11607 compliant) medical grade sterilization wrap by following the double wrap method or equivalent (ref: AAMI ST79, AORN Guidelines). 12

• Follow the case/tray manufacturer’s recommendations for loading and weight. Total weight of the wrapped case or tray should not exceed 11.4kg/25lbs. Sterilization • Moist heat/steam sterilization is the recommended method for the instruments. • Use of an approved chemical indicator (class 5) or chemical emulator (class 6) within each sterilization load is recommended. • Always consult and follow the sterilizer manufacturer instructions for load configuration and equipment operation. Sterilizing equipment should have demonstrated efficacy (e.g. FDA clearance, EN 13060 or EN 285 compliance,). Additionally, the manufacturer’s recommendations for installation, validation, and maintenance should be followed. • Validated exposure times and temperatures to achieve a 10-6 sterility assurance level (SAL) are listed in the following table. • Local or national specifications should be followed where steam sterilization requirements are more conservative than those listed in the table below. Cycle Type

Temperature

Exposure Time

Dry Time

United States Recommended Parameters Pre-vacuum / Vacuum Pulse Cycle Type

132°C / 270°F Temperature

4 minutes

Exposure Time

40 minutes Dry Time

European Recommended Parameters Pre-vacuum/ Vacuum Pulse

134°F / 273°F

3 minutes

40 minutes

Drying & Cooling • The recommended drying time for single wrapped instruments is 30 minutes unless otherwise noted in device specification instructions. • A 15 minute open door time is recommended after drying. • A 30 minute minimum cooling time is recommended after drying but longer times may be necessary because of load configuration, ambient temperature and humidity, device design, and packaging used. 13

Note: Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is a concern about TSE/CJD contamination are: 134°C/273°F for 18 minutes. These devices are compatible with these parameters. Storage • If using a sterilization container system with the GUSS instrument set, consult the manufacturer’s instructions for the validated term of sterility maintenance. • 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, showing signs of moisture, or appearing 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.

14

Symbols Used on Labeling1: Caution NON STERILE

Non-Sterile

U.S Federal law restricts this device to sale by or on the order of a physician CE Mark1 2797 EC

REP

CE Mark with Notified Body # 1

Authorized Representative in the European Community Manufacturer

Date of Manufacture REF



Batch Code

Catalog Number

Consult Instructions for Use Medical Device Quantity

Country of Manufacture

MATL Material SST

Stainless Steel Distributor

Refer to the labeling for CE information.

1

15

Manufactured by: 2797 EC REP Authorized Representative in the European Community: Symmetry Medical Manufacturing, Inc. Symmetry Medical Polyvac S.A.S 486 West 350 North Parc d’Activités du Moulin Warsaw, IN 46582 USA 139, Avenue Clément Ader Phone: +1 574 267 8700 Wambrechies www.tecomet.com 59118 France Phone: +33 3 28 09 94 54

Legal Name:

Distributed by: DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Ireland Phone: +353 214914000 www.depuy.com

7076 Rev D (02/22/2022)