BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3172277 · Received June 5, 2013

    Report

    Report Number
    1526350-2013-00292
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 8/23/2010 AND WAS LAST REPAIRED ON 12/27/2012. CUSTOMER IS A CADAVER TISSUE BANK WHICH EXPERIENCES HEAVY USAGE OF DEVICES. EVAL OF THE DEVICE OBSERVED THE ROLLER GEAR, SIDE PLATES AND ROLLER AND RATCHET GEAR WERE DAMAGED. PRIOR TO REPAIR THE DEVICE COULD NOT BE CHECKED FOR CALIBRATION DUE TO THE DAMAGE TO THE GEAR. THE CUSTOMER ALSO RETURNED TWO CUTTERS FOR EVAL. CUTTER EVAL DETERMINED THAT THE 1.5:1 CUTTER PRODUCED AN UNACCEPTABLE TEST MESH AND 2:1 CUTTER PRODUCED AN ACCEPTABLE TEST MESH. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING. 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 DAMAGED GEARS AND WAS NOT MESHING PROPERLY. THE FACILITY REPORTING THE EVENT IS A CADAVER TISSUE BANK. AS SUCH, THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249454 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)| 00-7703-015-00, SN# (B)(4)| ZIMMER SKIN GRAFT MESHER CUTTERS: