BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3030875 · Received March 28, 2013

    Report

    Report Number
    1526350-2013-00158
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SVC RECORD INDICATES THAT THE DEVICE IS 22 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2012. EVAL OF THE DEVICE VERIFIED THAT THE CUTTER WAS STUCK IN THE MESHER. PRIOR TO REPAIR, THE DEVICE COULD NOT BE CHECKED FOR CALIBRATION AND A TEST MESH COULD NOT BE PERFORMED DUE TO THE DAMAGE TO THE COMB AND THE STUCK CUTTER. PRIOR TO REPAIR, IT WAS OBSERVED THAT THE SIDE PLATES, ROLLER AND COMB WERE DAMAGED. 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 CUTTER WAS STUCK IN THE ZIMMER SKIN GRAFT MESHER. THROUGH INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE HAD A BENT COMB. ADDITIONAL CLINICAL FOLLOWING UP WITH THE HOSPITAL REVEALED THAT NO ADDITIONAL INFO WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127521 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-015-00, SN# (B)(4)