BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2093617 · Received April 6, 2011

    Report

    Report Number
    1526350-2011-00054
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE IS 10 YEARS OLD AND WAS SERVICED LAST ON (B)(6) 2010, FOR A NON RELATED ISSUE. A VISUAL INSPECTION FOUND THE DEVICE HAD A DAMAGED COMB. IN ADDITION, THE DEVICE WAS FOUND TO BE OUT OF CALIBRATION. THROUGH FURTHER TESTING OF THE DEVICE THE TECHNICIAN WAS ABLE TO PRODUCE AN ACCEPTABLY MESHED SAMPLE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, OR RE-PRODUCED FOR THE REPORTED COMPLAINT. WHILE THE DEVICE WAS SLIGHTLY OUT OF CALIBRATION, AND THE COMB DAMAGE WAS SO SLIGHT, THESE WOULD NOT HAVE CONTRIBUTED TO THE CAUSE OF THE REPORTED COMPLAINT. SHOULD THE CARRIER BE SLIGHTLY MISALIGNED WHEN STARTING THROUGH THE MESHER, THE RESULT WOULD LIKELY BE BUNCHING OF THE GRAFT AND JAMMING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER DID NOT WORK RIGHT. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL ON (B)(6) 2011, INDICATED THAT A LARGE GRAFT HARVEST WAS MESHED ON A 8" CARRIER, THE CARRIER DID NOT PASS STRAIGHT THROUGH AND GOT JAMMED. GRAFT WAS SALVAGED AND USABLE; NO ADDITIONAL HARVEST AND NO DELAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1