OFFSET CUP IMPACTOR Important Medical Information

WARNINGS AND PRECAUTIONS Enztec devices should only be used by surgeons who are fully familiar with the surgical technique required and who have been trained to this end. The operating surgeon must take care not to exert inappropriate stress on the device and must fully comply with the operating procedure described in the Surgical Protocol. Incorrect maintenance, cleaning or handling may render the device(s) unsuitable for its intended use, cause corrosion, dismantling, distortion and/or breakage, or cause injury to the patient or operating staff. Enztec shall not be responsible in the event of a device being used which is damaged, incomplete, showing signs of excessive wear and tear, or that has been repaired or modified (either permanently or temporarily) outside the control of Enztec or its representatives. As a result of mechanical features required, the device(s) is made of non implantable materials. In the event of the device breaking, no fragment must remain in the patient as this could cause post-operative complications such as allergies, infections, or complications of a biological nature associated with the release of non-implantable components, possibly requiring further intervention. The surgeon must take care not to use the OCI to exert inappropriate stress on the pelvis or implants. Do not use any device to extend the length of the OCI, as this may result in excessive forces being applied to the OCI or implant, or cause patient harm. The OCI must not be used to retract or disengage implants. Do not use excessive force when attaching the acetabular shell to the OCI. Only light finger tightening is required. The OCI should only be impacted using standard Stryker surgical mallets on the anvil face. Do not impact the OCI laterally or apply large lateral forces to the OCI, as applying such loads may result in damage to the implant or instrument, or cause patient harm. STORAGE The OCI should be stored in individual packages or in containers. After use it must be stored in a clean, dry and temperate place. DISPOSAL Devices must be disposed of in accordance with the health care facility’s procedures, ensuring protection from physical hazards such as exposed edges. Care must be taken to ensure that used devices are decontaminated following the cleaning and sterilisation instructions described within this document, or otherwise disposed of as infectious waste. Devices should be destroyed in a manner that prevents potential reuse. SCHEDULED MAINTENANCE Like any precision surgical instrument the OCI should undergo regular servicing by Stryker, Enztec or authorised personnel to ensure that the instrument remains in good condition and continues to act as intended. Such servicing should be carried out every 12 months or sooner if the instrument is exhibiting signs of wear and damage. During this servicing, the Collet (MIH-004-07) must be replaced.

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CLEANING AND STERILISATION For safety reasons, non-sterile devices must be pre-cleaned, cleaned and sterilised before use. Moreover, for good maintenance, reusable devices must be pre-cleaned, cleaned and sterilised after surgery following the sequence of steps described in the following chart: 1. Point of Use

-- Remove gross contamination

2. Transport to Processing Area

-- Avoid damage -- Minimise time before cleaning

3. Preparation for Cleaning

-- Disassemble where possible following disassembly instructions in the cleaning guide

4. Pre-cleaning

-- Submerge in enzymatic detergent prepared according to manufacturer’s recommendations -- Soak for 15 minutes at 40°C (104°F) -- Scrub while submerged with soft sponge and agitate -- Use pipe cleaner or non-metallic brush for lumens and crevices. Actuate moving parts to loosen trapped soil -- Rinse in 38°C-49°C (101°F-120°F) tap water for 1 minute -- Thoroughly flush all lumens and difficult to reach areas -- Actuate while rinsing -- Soak in ultrasonic bath in neutral pH detergent (Neutrad or acceptable alternative), prepared according to manufacturer’s recommendations -- Clean for 15 minutes at 40°C (104°F) -- Rinse with clean, tap water, actuating moving parts while rinsing, for 1 minute; repeat rinse twice -- Dry thoroughly with clean, lint-free cloth

5. Cleaning

6. Inspection

-- Inspect for contaminants and damage -- Repeat cleaning if contaminants remain -- Contact Enztec or its representatives if device is damaged

7. Preparation for Sterilisation

-- Reassemble where possible following assembly instructions -- Package loosely in suitable pouch or cloth wrap

8. Sterilisation

-- Steam sterilisation, Pre-vacuum cycle -- Temperature: 134°C (273°F) -- Exposure Time: 4 minutes -- Dry Time: 60 minutes

Other sterilisation methods are possible but must be validated beforehand. Automatic cleaners and autoclaves must be validated by the hospital and regularly checked to guarantee the recommended sterilisation temperatures are reached for the entire exposure time. If sterilisation containers with paper filters are used, it is advisable to use a new filter for each sterilisation. If after having followed this sterilisation method there is still water in the sterilisation containers or on/inside the device, the device must be dried and sterilisation repeated.

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COMPLAINTS Any health professional having a complaint or grounds for dissatisfaction relating to the quality of the product, its identity, its durability, its reliability, safety, effectiveness and/or its performance, should notify Enztec, Stryker or their representatives. Moreover, if the device has malfunctioned, or is suspected of having malfunctioned, Enztec, Stryker or their representative must be advised immediately. If an Enztec product has ever worked improperly and could have caused or contributed to a serious incident, serious injury, or death, Enztec or their representative, as well as the competent authority of the Member State in which the user and/or patient is established, must be informed as soon as possible by telephone or in writing. For all complaints, please include the device name and catalogue number, a full description of any markings, contact name and address, and an exhaustive description of the event to help Enztec understand the causes of the complaint. Please retain the device for investigation purposes. WARRANTY STATEMENT Enztec devices are manufactured for use only by qualified medical personnel who are trained in their use. All Enztec devices are warranted to be free from defects in workmanship and materials for one (1) year from the date of sale. Any Enztec device with a defect during the applicable warranty period will be repaired or replaced. Enztec shall not be liable, expressly or impliedly, for: a. Any damages which arise or are caused, whether by the customer or by any of the users of the devices or equipment, as a result of i. misuse, mishandling, and/or improper operation ii. repairs, modifications, or alterations performed by any person or entity other than Enztec, or their authorised representatives iii. incorrect or incomplete inspection, cleaning and/or maintenance, or iv. use in combination with adaptors and/or equipment, or use in any manner or medical procedure, other than those for which it is designed; and b. Any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the device and equipment. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND ALL OTHER OBLIGATIONS OR LIABILITIES ON ENZTEC’S BEHALF. Enztec neither assumes nor authorizes any person to assume for it any other liabilities in connection with the sale of said devices and equipment. To ensure proper use, handling, and care of devices and equipment, consult the applicable catalogue, brochure, instruction manual, teaching film, and other literature which is included with the product and/or otherwise available from the company, upon request. For further information relating to the use of this device or complaints please contact your Enztec representative or distributor. Caution: Federal law restricts this device to sale or use by or on the order of a licensed physician. SYMBOL TRANSLATION - see enztec.com/ifu

DIST

Distributed by

MD

Medical device

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Enztec Limited 3/17 Print Place Middleton Christchurch 8024 NEW ZEALAND Tel: +64 3 348 0203 Email: [email protected]

Advena Ltd. Tower Business Centre, 2nd Flr. Tower Street Swatar BKR 4013 MALTA

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Part No.: 10692-02 2020/05 Rev: 9