ANTERIOR APPROACH HIP EXPOSURE INSTRUMENTS Instructions for Use and Reprocessing

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INSTRUCTIONS FOR USE AND REPROCESSING FOR THE ANTERIOR APPROACH HIP EXPOSURE INSTRUMENTS Description The Anterior Approach Hip Exposure instruments made by Tecomet are reusable hand held devices designed to provide a surgeon with all the instrumentation needed to gain access to the hip joint during a total hip arthroplasty (THA) procedure utilizing the anterior approach technique; e.g. retractors, bone hooks, T-handles, elevators, femoral head corkscrews, canal finder, ligamentum teres cutter. The anterior approach surgical technique is considered less invasive because it requires less cutting of surrounding muscle tissue but joint access is more difficult.

Intended Use The Anterior Approach Hip Exposure instruments are reusable hand held instruments that enable a surgeon to expose and gain access to the hip joint during a total hip arthroplasty (THA) procedure utilizing the anterior approach technique. Intended Patient Population The instruments are prescriptive, and therefore a knowledgeable orthopedic surgeon may utilize the instruments on any patient he or she deems applicable. The instruments are to be used on patients undergoing total hip arthroplasty.

Indications For use The instruments are reusable surgical instruments that are designed to aid in the exposure of the hip joint during a muscle sparing anterior surgical approach Contra-Indications The instruments are prescription use and are only to be used by qualified health care personnel. There are no contra-indications for the instruments. Intended User The instruments 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 instruments assist in the exposure of the hip joint during the muscle sparring surgical approach.

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.

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Adverse Events and 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. Performance Characteristics The instruments aid the surgeon to expose and gain access to the hip joint during a total hip arthroplasty (THA) procedure utilizing the anterior approach technique.

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. WARNINGS AND PRECAUTIONS

Warnings • All Anterior Approach Hip Exposure instruments are provided

NON-STERILE and must be properly cleaned and sterilized prior to each use. • Read these instructions completely before using the devices. • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of the devices. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated instruments. • Never use metal brushes or steel wool for cleaning. • Ensure firm connection with the assembled device prior to use. NON STERILE

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

Precautions • U.S Federal law restricts this device to sale by or on the order of a physician. • The instruments should be inspected for damage prior to each use. Instruments that show signs of damage or degradation should not be used. • Safety caps and other protective packaging material must be removed from the instruments prior to the first cleaning and sterilization. • 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. • Careful attention must be paid to asepsis and avoidance of anatomical hazards. 2

Limitations of Reprocessing Repeated processing according to these instructions has minimal affect on the instruments. End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended use or misuse and not reprocessing.

CLEANING • Tecomet recommends that the instruments be cleaned as soon as possible after each surgical procedure 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 distilled or sterile water for rinsing is recommended. Avoid using hot water as this will coagulate and harden protein based soil. • 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. A. Manual Method 1. Prepare a solution of proteolytic enzymatic detergent according to the manufacturer’s recommendations. 2. Before cleaning, disassemble the T-handle from any corkscrew devices that are still attached by pulling back on the quick connection release collar on the handle and removing the corkscrew instrument. 3. Immerse instruments and soak for the time recommended by the detergent manufacturer.

4. 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 of each device that will pose a challenge to effective cleaning; e.g. rough surfaces, threads and cutting features. 5. Rinse thoroughly with distilled or sterile water until all traces of cleaning solution are removed.

6. Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature recommended by the detergent manufacturer.

7. Submerge the instruments and activate the bath for a minimum of 10 minutes. A frequency of 25 – 50 kHz is recommended.

8. 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. 9. Visually inspect the instruments for visible soil and repeat these cleaning steps if remaining soil is observed.

10. Dry the instruments with clean, lint-free wipes in preparation for sterilization. Use clean pressurized air to remove moisture from hard to reach areas. B. Automated Washer-Disinfector Method 1. Prepare a solution of proteolytic enzymatic detergent according to the manufacturer’s recommendations. 2. Before cleaning, disassemble the T-handle from any corkscrew devices that are still attached by pulling back on the quick

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connection release collar on the handle and removing the corkscrew instrument.

3. Immerse instruments and soak for the time recommended by the detergent manufacturer.

4. 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 of each device that will pose a challenge to effective cleaning; e.g. rough surfaces, threads and cutting features. 5. Rinse thoroughly with distilled or sterile water until all traces of cleaning solution are removed. 6. Load instruments in an automated washer-disinfector in a manner that maximizes exposure of the instrument surfaces.

7. Operate the washer-disinfector according to the manufacturer’s instructions to ensure all cycle parameters (i.e. time, temperature) are followed.

8. 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 or use clean pressurized air to remove moisture from hard to reach areas in preparation for sterilization. STERILIZATION Moist heat/steam sterilization is the preferred and recommended method for the Anterior Approach Hip Exposure instruments. Instruments must be properly cleaned before sterilization.

Place instruments in appropriate container that allows steam to penetrate and make direct contact with all surfaces. Use only approved sterilization wraps and follow container manufacturer’s recommendations for load size. The recommended parameters for steam sterilization are:

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Sterilization Mode

Exposure Temp.

Exposure Time

Dynamic-Air-Removal

132°C (270°F)

4 minutes

Symbols Used on Labeling: Caution. Consult Accompanying Documents

NON STERILE

STERILE

Non-Sterile 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

Lot Number



Consult Instructions for Use

Catalog Number Medical Device

Unique Device Identifier Packaging Unit

Country of Manufacture Distributor

Additional Labeling: “MANUAL USE ONLY”

“REMOVE FOR CLEANING & STERILIZATION”

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.

Refer to the labeling for CE information

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Manufactured by:

2797

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

7023-99 Rev G (09/19/2022)

EC 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