BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3172278 · Received June 5, 2013

    Report

    Report Number
    1526350-2013-00293
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 2/21/2002 AND WAS LAST REPAIRED ON 9/6/2012 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED THAT THE RATCHET GEAR WAS STUCK ON THE ROLLER. IT WAS ALSO OBSERVED THAT THE ROLLER, COMB, SIDE PLATES AND GEAR WERE DAMAGED. A TEST MEAN AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. THE COMPLAINT WAS LIKELY CAUSED BY ROLLER AND RATCHET GEAR DAMAGED DUE TO IMPROPER HANDLING BY THE CUSTOMER. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS BROKEN. DURING DEVICE ANALYSIS, IT WAS DETERMINED THAT THE COMB WAS BENT. CLINICAL FOLLOW UP WITH THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFO REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249371 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER SKIN GRAFT MESHER CUTTERS:| 00-7703-020-00, SN# (B)(4)| 00-7703-030-00, SN# (B)(4)