ZIMMER INSTRUMENT -PROVISIONAL USE, CARE AND STERILIZATION Instruction Manual

ENGLISH

Rev. D August 2020 © 2020, 2012, Zimmer, Inc.

87‑6203‑991‑99 EN Rev. D

INSTRUMENT/PROVISIONAL USE, CARE AND STERILIZATION

2797

Zimmer, Inc. 1800 W. Center Street Warsaw Indiana 46580 USA 1‑800‑348‑2759 (US only) +1‑574‑372‑4999

1AMEN876203991991 ENGLISH

EN

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INSTRUMENT/PROVISIONAL USE, CARE AND STERILIZATION This instruction manual provides information on the care, cleaning, disinfection, maintenance and sterilization of manual surgical instruments. Before using a product placed on the market by Zimmer, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.g., product literature, written surgical technique). Surgical instruments are intended to be used by surgeons trained to perform orthopedic surgical procedures, facility central process staff trained to handle, clean and resterilize surgical devices, and sales representatives who interact with Health Care Professional and Surgery Center Staff. Zimmer is not liable for complications that may arise from use of devices in circumstances outside of Zimmer’s control including, but not limited to, product selection and deviations from the device’s indicated uses or surgical technique.

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The CE mark is valid only if it is also printed on the product label.

These items are medical devices as identified with the symbol on the package label. Sterile devices are identified as such with the sterile symbol on the package label. The symbol indicates Gamma sterilization,

indicates Ethylene Oxide sterilization, indicates steam or dry heat and indicates sterilization using aseptic processing techniques. Devices which are provided non-sterile may

be identified with the symbol or on the package label. Reusable medical devices sold sterile may be reprocessed using these instructions. Single use devices sold sterile may be reprocessed if not used unless labeling indicates the instrument is not to be reprocessed as indicated by the Do Not Resterilize symbol on the package label . Devices which are provided sterile and cannot be resterilized if the packaging or sterile barrier is damaged are indicated as such with the

symbol on the package label.

INDICATIONS FOR USE AND CONTRAINDICATIONS When used uniquely for a particular implant system, consult that system’s labeling for the detailed indications, contraindications, performance characteristics and expected clinical benefits for the devices. The clinical benefits of the instruments are primarily to facilitate appropriate alignment, sizing, implantation and explanation of associated implants. INSTRUMENT/PROVISIONAL CARE • Failure to follow these instructions could result in instrument or provisional breakage and potential adverse effects on user(s) or patient. • Use only instruments and provisionals specifically designed for use with their associated devices. • Misuse reduces useful life and/or increases injury risk. • Unless otherwise specified, rulers and calipers with measurements indicated on a scale are accurate to within +/- one‑half the smallest division on the scale. • Any complaints should be reported to Zimmer Biomet using the Product Experience Report Form (Form number CF04001) to [email protected]. Serious adverse events shall be reported to the Competent Authority of the respective EU Member State in which the event occurred. WARNINGS • Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. Do not use devices suspected to be unclean. • Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents. • Do not use cutting/sharp instruments with dull or deformed edges or instruments/provisionals that are deformed, corroded, damaged or worn. They may not perform as intended. • Do not subject instruments to high loads and/or impact as breakage can occur. • Do not subject plain or anodized aluminum or titanium components to acidic or alkaline cleaning agents or stainless steel to chlorine or chloride-based agents. Corrosion or discoloration may occur. • Do not clean polyetherimide components with phenol-based detergents. Crazing or cracking may occur. • Disinfection is only acceptable as an adjunct to full sterilization for reusable surgical instruments and provisionals. • The presence of substances greater than a concentration of 0.1% weight/weight which are carcinogenic, mutagenic or toxic to reproduction (CMR), or endocrine disruptors (ED), are identified on the product label the

symbol.

PRECAUTIONS • Inspect all instruments/provisionals carefully prior to each use. If needed, resharpening must be done by the manufacturer to ensure proper device performance. -- See Reusable Instrument Lifespan Manual 1219 for guidance on determining reusable instrument suitability for use. • Polymer provisionals may show eventual surface degradation from the heat and chemicals used in hospital cleaning and steam sterilization. When degradation makes cleaning difficult or if the surface becomes chalky, replace the provisional. • Rasps-A rasp must advance each time it is struck with a mallet. There is a higher risk of bone fracture or rasp impaction when it is not advancing or if the rasp is dull.

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Cannulated Instruments-Clean cannulated instruments intraoperatively to prevent accumulation of debris. Guide Wires-Check the guide wire position frequently using fluoroscopy to prevent unintended guide wire advancement and/or penetration into the surrounding tissues. Metal instruments or fragments can be located by radiography or fluoroscopy. Nonmetal instruments or fragments may not be located by radiography or fluoroscopy, and should be accounted for at the end of the surgical procedure. Any decision to remove a broken drill or drill fragments is left to the surgeon’s discretion and must take into account the associated risks. Any decision not to remove broken or fragmented instruments is also at the surgeon’s discretion and must take into account the associated risks.

POSSIBLE ADVERSE EFFECTS Review the package insert of the associated implant system for a list of possible adverse effects that could come from its use. CLEANING • Where applicable, disassemble instruments prior to cleaning. -- See Instrument Assembly and Disassembly Manual 1258 under Disassembly Manual/Reusable Instrument Lifespan Manual (https://www.zimmerbiomet.com/medical-professionals/support.html) for detailed guidelines related to assembling and disassembling. • Thoroughly clean, rinse, and dry reusable instruments immediately after use to minimize corrosion and potential crosscontamination. -- See Orthopedic Reusable Devices 97‑5000‑170‑00 under Reusable Device Reprocessing Instructions (www.zimmerbiomet.com/medical-professionals/support.html) for detailed guidelines related to point-of-use preparation; proper cleaning, care, maintenance, and handling of surgical instruments; and an explanation of associated symbols. INSPECTION AND FUNCTIONAL TESTING • Carefully inspect each device to ensure that all visible blood and soil has been removed prior to use. Do not use any device suspected to be unclean. • • • • •

If the Do Not Use If Package Damaged (Pack Damaged) symbol is present on the label, do not use the device if the package is damaged or broken. Check the action of moving parts (such as hinges and box locks) to ensure smooth operation throughout the intended range of motion. Check instruments with long slender features (particularly rotating instruments) for distortion. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your Zimmer representative for a replacement. -- See Reusable Instrument Lifespan Manual 1219 under Disassembly Manual/Reusable Instrument Lifespan Manual for detailed guidelines related to determining reusable instrument suitability for use (www.zimmerbiomet.com/medical-professionals/support.html).

MAINTENANCE • If necessary, hinged, rotating, or articulating instruments can be lubricated with an instrument product specifically designed for compatibility with steam sterilization. TRANSPORTATION • Transport instruments in their designated instrument trays. • Instrument trays ensure that every instrument is kept in a way that they do not receive any damage and that their functionality is preserved during transportation. DISCLOSURE OF RESIDUAL RISKS • Review the package insert of the associated implants for a list of residual risks associated with the use of that system. STERILIZATION INSTRUCTIONS • These sterilization instructions are consistent with ANSI/AAMI/ISO standards and guidelines. They should be used for items supplied non-sterile, reprocessing reusable devices and sterile or reusable items that were opened but unused. • In the event of inadvertent loss of sterility while preparing for surgery, sterile, single use metal instruments may be sterilized only once for immediate use, following the recommended sterilization specifications of the manufacturer. Do not use the original plastic cavities or lids for resterilization. -- See Orthopedic Reusable Devices 97‑5000‑170‑00 under Reusable Device Reprocessing Instructions (www.zimmerbiomet.com/medical-professionals/support.html) for detailed guidelines related to proper care, maintenance, sterilization, handling of surgical instruments, and an explanation of associated symbols. • Sets of devices may be loaded into general or dedicated trays. Use a medical grade sterilization pouch or wrap (double wrap method – ANSI/AAMI ST79). Use only FDA cleared wraps in the United States. •

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Do not reuse instruments or devices labeled for single use only if indicated by the Do Not Reuse symbol on the package label. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.