BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3172276 · Received June 5, 2013

    Report

    Report Number
    1526350-2013-00291
    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 7/3/1992 AND WAS LAST REPAIRED ON 12/19/2012. EVAL OF THE DEVICE OBSERVED THAT THE COMB WAS DAMAGED. IT WAS ALSO OBSERVED THAT THE ROLLER, GEAR, AND SIDE PLATES WERE DAMAGED, AND THE SCREWS WERE STRIPPED OUT AS WELL. A TEST MESH AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. THE CUSTOMER INCLUDED FOUR CUTTERS. CUTTER EVAL DEMONSTRATED THAT ALL FOUR CUTTERS PRODUCED UNACCEPTABLE TEST MESHES. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING AND LACK OF PREVENTATIVE MAINTENANCE. 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
    249144 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-020-00, SN# (B)(4)| ZIMMER SKIN GRAFT MESHER CUTTERS:| 00-7703-040-00, SN# (B)(4)| 00-7703-015-00, SN# (B)(4)| 00-7703-030-00, SN # (B)(4)