Instrument / Provisional Use , Care and Sterilization Instruction Manual

ENGLISH

Rev. D 2021‑11‑11 © 2021, 2012, Zimmer, Inc.

87‑6203‑999‑99 EN Rev. D

INSTRUMENT/PROVISIONAL USE, CARE AND STERILIZATION 1AMEN876203999991 ENGLISH

Zimmer, Inc. 1800 W. Center Street Warsaw 2797 Indiana 46580 USA 1‑800‑348‑2759 (US only) +1‑574‑372‑4999 www.zimmerbiomet.com https://labeling.zimmerbiomet.com

EN

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

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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 Professionals 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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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. Patients/users hypersensitive to any of the instruments material (e.g. cobalt, chromium, nickel) may suffer an allergic reaction. The duration of the contact between instruments and patient/users is transient. If you have any concerns for potential allergic reactions, please contact your Zimmer Biomet sales representative. One or more components of this device contain the following substance defined as CMR 1B substances in a concentration above 0.1% weight by weight, when identified on the product label with the symbol: Cobalt: CAS No. 7440‑48‑4. There are a few case studies in which patients were diagnosed with cancer while having a device manufactured from cobalt containing alloys in place that hypothesized at a causal nexus between the device and the diagnosis. However, current overwhelming peer-reviewed scientific evidence supports that the incidence of developing cancer or suffering from adverse reproductive effects for patients with a device manufactured from cobalt containing alloys or stainless steel alloys containing cobalt is comparable to the respective incidence for the general population. Except where specifically instructed otherwise, do NOT permanently implant Steinmann pins or K‑wires. K‑wires should be used for temporary fracture reduction and as guides for placement of implants.

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

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Gamma sterilization, or dry heat and

MATERIAL PRECAUTIONS • Nickel, classified as skin sensitiser 1: sensitisation or allergic reaction to users and/or patients. Classification based on applicable EU legislation for chemical substances. • Elemental cobalt, is classified as a carcinogen, mutagen and toxic to reproduction (CMR) 1B substance, specifically carcinogen 1B, reprotoxin 1B and mutagen 2. While the CMR1B classification of cobalt applies to all routes of exposure it is based on rodent studies looking at the inhalation of elemental cobalt (i.e. pure cobalt) and cobalt oxide dust, whereas this medical device is manufactured from a cobalt containing alloy (i.e. a mixture of cobalt, other metals and chemical elements). Cobalt containing alloys have physical and chemical properties that are distinct from pure cobalt, cobalt oxide dust or soluble cobalt compounds [1, 2, 3]. In addition, if implantable medical devices manufactured from a cobalt containing alloy are used in accordance with the intended purpose, inhalation exposure is not possible. There are a few case studies in which patients were diagnosed with cancer while having a device manufactured from cobalt containing alloys in place that hypothesized at a causal nexus between the device and the diagnosis. Current overwhelming peer-reviewed scientific evidence and a Zimmer Biomet risk assessment related to cobalt release from long-term implanted medical devices during normal conditions of use conclude that the incidence of developing cancer or suffering from adverse reproductive effects from cobalt are negligible. Cobalt containing alloys are included in ISO 21534 as materials found acceptable for the manufacture of implantable medical devices due to their proven long-term clinical usage. No implantable medical device is completely free of adverse effects when implanted in the human body. For appropriate applications, introducing these materials into the body is acceptable.

indicates Ethylene Oxide sterilization, indicates steam indicates sterilization using aseptic processing techniques. Devices which are

provided non-sterile may be identified with the symbol 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.

INTENDED PURPOSE Instruments are intended to facilitate the implantation and explantation of the corresponding compatible Zimmer Biomet implants. Instruments cases/trays are intended to facilitate the organization, identification, storage, transportation, and sterilization reprocessing of the compatible Zimmer Biomet Instruments. 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 explantation 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.

PRECAUTIONS • Inspect all instruments/provisionals carefully prior to each use. If needed, resharpening must be done by the manufacturer to ensure proper device performance. • 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. • 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.

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