BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3140167 · Received May 29, 2013

    Report

    Report Number
    1526350-2013-00274
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    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 EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 09/08/2010 AND WAS LAST REPAIRED ON 12/06/2012. CUSTOMER IS A CADAVER TISSUE BANK WHICH EXPERIENCES HEAVY USAGE OF DEVICES. EVALUATION OF THE DEVICE OBSERVED THE ROLLER GEAR TO BE DAMAGED. IT WAS ALSO OBSERVED THAT THE ROLLER, COMB AND RATCHET GEAR WERE DAMAGED. PRIOR TO REPAIR THE UNIT WAS OUTSIDE OF CALIBRATION SPECIFICATIONS ON THE LEFT SIDE. CUSTOMER INCLUDED TWO CUTTERS, AND EVALUATION DEMONSTRATED THAT 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 GEARS ON THE ZIMMER SKIN GRAFT MESHER WERE DAMAGED. FACILITY REPORTING INFORMATION IS A CADAVER TISSUE BANK, THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236900 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-020-00 SN (B)(4)| SN (B)(4)| ZIMMER SKIN GRAFT CUTTER 00-7703-015-00,