BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3823781 · Received February 20, 2014

    Report

    Report Number
    1526350-2014-00103
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, UNITED STATES AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAFT MESHER. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 09/09/1996 AND WAS LAST REPAIRED ON 02/17/2013. EVALUATION OF THE DEVICE OBSERVED THAT THERE WAS DAMAGE TO THE COMB, ROLLER AND ROLLER GEAR. THE CUSTOMER RETURNED FOUR CUTTERS AND ALL CUTTERS PASSED EVALUATION. THE CUSTOMER RETURNED A 2195 RATCHET WITH THE DEVICE. USAGE OF A 2195 RATCHET AS OPPOSED TO THE 7701 RATCHET LIKELY CAUSED THE DAMAGE TO THE ROLLER AND RATCHET GEAR. ADDITIONALLY, LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING WAS LIKELY THE CAUSE FOR THE DISCOLORATION AND WEAR TO THE SIDE PLATES. CUSTOMER DID NOT RETURN ANY CARRIERS FOR EVALUATION. THE DEVICE HAS NOT BEEN RETURNED TO ZIMMER SURGICAL IN THREE YEARS. LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING BY THE USER LIKELY CAUSED THE DAMGE TO THE COMB, WHICH MOST LIKELY CAUSED THE CUSTOMERS REPORTED EVENT. THE DEVICE WAS SERVICES AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN TISSUE WAS FED THROUGH THE ZIMMER SKIN GRAFT MESHER. IT WAS NOT COMING OUT EVENLY, AND IT SEEMED BENT. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THERE WA NO PT INJURY ASSOCIATED WITH THE REPORTED ISSUE. THE GRAFT WAS CAUGHT IN THE MACHINE AND WAS DAMAGED BUT IT WAS ABLE TO BE USED AND AN ADDITIONAL UNPLANNED GRAFT HARVEST WAS NOT REQUIRED FROM THE PT. SURGICAL TIME WAS EXTENDED IN ORDER TO CAREFULLY REMOVE THE GRAFT FROM THE MESHER AND MINIMIZE DAMAGE TO THE GRAFT; THE AMOUNT OF TIME SURGERY WAS EXTENDED WAS NOT REPORTED. THE SURGICAL PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106703 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER CUTTER: 00-7703-020-00, SN (B)(4)| ZIMMER CUTTER: 00-7703-030-00, SN (B)(4)| ZIMMER CUTTER: 00-7703-015-00, SN (B)(4)| ZIMMER CUTTER: 00-7703-040-00, SN (B)(4)