BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 1243084 · Received November 21, 2008

    Report

    Report Number
    1526350-2008-00043
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US

    Narratives

    Additional Manufacturer Narrative · 1

    CUTTER WAS NOT RETURNED FOR EVALUATION. DEVICE WAS RETURNED FOR EVALUATION AND FOUND TO BE OUT OF CALIBRATION BY .002" PRIOR TO REPAIR. DAMAGED COMB WAS REPLACED. DEVICE INSTRUCTION MANUAL STATES "TO RETURN DEVICE TO MANUFACTURER EVERY 12 MONTHS FOR INSPECTION/PREVENTATIVE MAINTENANCE". ANNUAL CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTACT ACCURACY. DEVICE LAST IN FOR SERVICE WAS APRIL 2006.

    Description of Event or Problem · 1

    OPERATING ROOM SAID THE MESHER DESTROYED A SKIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER SKIN GRAFT MESHER SKIN GRAFT MESHER FZW ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1