BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3880773 · Received April 9, 2014

    Report

    Report Number
    1526350-2014-00258
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 12/15/2009 AND WAS LAST REPAIRED ON 07/18/2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE COMB AND SIDE PLATES OF THE DEVICE. PRIOR TO REPAIR, BOTH THE TEST MESH AND THE CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. REPAIR OF THIS DEVICE INCLUDED REPLACEMENT OF THE COMB, ROLLER, BALL DETENTS AND BOTH SIDE PLATES. THE CUSTOMER DID NOT RETURN A RATCHET OR ANY CUTTERS FOR EVALUATION. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED. NO INFORMATION IS KNOWN ABOUT THE CUTTER(S) OR RATCHET UTILIZED DURING THE REPORTED EVENT; HOWEVER, IMPROPER HANDLING BY THE CUSTOMER MOST LIKELY LED TO THE DAMAGE TO THE COMB, WHICH COULD HAVE CAUSED THE CUSTOMER'S REPORTED EVENT. 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 NOT FEEDING SKIN THROUGH. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214022 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1