BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2230814 · Received August 23, 2011

    Report

    Report Number
    1526350-2011-00173
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 15 YRS OLD AND HAS NOT BEEN IN FOR SERVICE SINCE PURCHASED. THE INSPECTION FOUND THE UNIT WAS RECEIVED WITH A BADLY DAMAGED COMB. THE CAUSE OF THE REPORTED COMPLAINT WAS THE USER KNOWINGLY USING A DAMAGED DEVICE. CLINICAL FOLLOW UP INDICATED THE DEVICE WAS USED KNOWING IT HAD A DAMAGED COMB, AND SUBSEQUENTLY THE GRAFT WAS NOT USEABLE. A DAMAGED COMB MAY NOT ALLOW THE CUTTER TO INTERACT WITH THE GRAFT CORRECTLY, AND CAN RESULT IN A NUMBER OF SCENARIOS, E.G. GRAFT STICKING TO COMB/CUTTER, GRAFT BEING TORN OR SHREDDED, GRAFT NOT FEEDING THROUGH THE DEVICE CORRECTLY. 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 NOT SERVICED AND WILL NOT BE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER ALLEGEDLY DAMAGED THE GRAFT. THE DOCTOR HAD TO TAKE ANOTHER SKIN GRAFT FROM A SEPARATE SITE. ADD'L CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE SURGEON WAS AWARE THE COMB WAS BENT ON THE MESHER PRIOR TO USE. THERE WAS NO OTHER DEVICE AVAILABLE SO SURGEON USED IT ANYHOW. THE INITIAL GRAFT WAS RUINED, AND AN ADD'L GRAFT WAS HARVESTED. THIS SKIN GRAFT WAS MESHED BY A KNIFE BLADE. FOLLOWING THE PROCEDURE THE SURGEON BEAT THE MESHER WITH THE RATCHET HANDLE. NO DELAY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR