BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 4998736 · Received August 12, 2015

    Report

    Report Number
    1526350-2015-00147
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ZIMMER BIOMET SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED ON 8/10/2006 AND WAS PREVIOUSLY REPAIRED 9/22/2011 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED THE COMB WAS EXCESSIVELY DAMAGED AND DEFORMED. THERE WAS ALSO DAMAGE TO THE SIDE PLATES, HINGES, ROLLER, SHOULDER BOLTS, WASHERS AND ROLLER GEAR. PRIOR TO REPAIR, REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE SIDE PLATES, BEARINGS, ROLLER GEAR, ROLLER, COMB, SCREWS, COMB SPRINGS, SHOULDER BOLTS, HINGE TOPS, BALL DETENTS, WASHERS AND LATCHING PIN. THE REPORTED EVENT WAS MOST LIKELY DUE TO THE EXCESSIVELY DAMAGED COMB, WHICH WAS MOST LIKELY DUE TO IMPROPER HANDLING BY THE USER. IT SHOULD BE NOTED, PER THE INSTRUCTIONS FOR USE, "THE ZIMMER SKIN GRAFT MESHER SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY." THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE INITIAL GRAFT HARVEST WAS TORN, RIPPED, SHREDDED AND UNUSABLE. ADDITIONAL CLINICAL INFORMATION DETERMINED THAT THE ISSUE OCCURRED DURING A SURGICAL PROCEDURE. AS A RESULT OF THE DAMAGED GRAFT, AN ADDITIONAL UNPLANNED GRAFT HARVEST WAS REQUIRED TO COMPLETE THE SURGERY. AN ALTERNATE DEVICE WAS RETRIEVED AND USED TO COMPLETE THE SURGERY WITHOUT ANY KNOWN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531425 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER BIOMET SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1