BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 1993837 · Received January 13, 2011

    Report

    Report Number
    1526350-2011-00009
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THE DEVICE IS 2 YEARS OLD AND HAS BEEN PREVIOUSLY RETURNED FOR SERVICE. A VISUAL INSPECTION FOUND THE GEARS WERE DAMAGED AND THE COMB WAS BENT. TWO CUTTERS WERE RETURNED WITH DEVICE AND ONE PRODUCED AN UNACCEPTABLE CUT, AND THE OTHER PRODUCED AN ACCEPTABLE CUT. THE CAUSE OF THE REPORTED ISSUE WAS DUE THE DEVICE DAMAGE. ALL THE INSPECTION FINDINGS ARE CAUSES FOR POOR MESHING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER DAMAGED THE GRAFT. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL ON (B)(6) 2010 INDICATED THAT THE GRAFT OBTAINED WAS USABLE AND NO ADDITIONAL HARVEST WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1