BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3871213 · Received April 16, 2014

    Report

    Report Number
    1526350-2014-00287
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 04/12/1996 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED BENT TINES ON THE COMB. ALSO, THE UPPER AND LOWER GEAR GUARDS WERE MISSING FROM THE DEVICE. PRIOR TO REPAIR, BOTH THE TEST MESH AND THE CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. REPAIR OF THIS DEVICE INCLUDED REPLACEMENT OF THE COMB, ROLLER, ROLLER GEAR, BOTH SIDE PLATES, UPPER AND LOWER GEAR GUARDS, BOTH LATCHING PINS AND THE LEFT AND RIGHT HINGED TOPS. THE CUSTOMER DID NOT RETURN A RATCHET OR ANY CUTTERS FOR EVALUATION. THIS DEVICE HAS NOT BEEN RETURNED TO ZIMMER SURGICAL FOR MAINTENANCE OR REPAIRS SINCE MANUFACTURE 18 YEARS AGO; THEREFORE, LOCK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING BY THE CUSTOMER MOST LIKELY CAUSED THE DAMAGE TO THE COMB OF THE DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER HAD A DAMAGED COMB. THERE WAS NO PT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233406 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1