BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER COMPLEX

    MDR report key: 3831850 · Received March 6, 2014

    Report

    Report Number
    1526350-2014-00163
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 10/24/1991 AND WAS LAST REPAIRED ON 11/26/2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED FLATTENED TINES TO THE RIGHT SIDE OF THE COMB. A RETURNED CUTTER HAD NO SERIAL NUMBER THIS CUTTER DID NOT GET TESTED, DUE TO THE LACK OF SERIAL NUMBER. ALSO THE TEST MESH WAS NOT PERFORMED DUE TO THE DAMAGED COMB. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMB. THE CAUSE OF THE REPORTED ISSUE WAS IMPROPER HANDLING BY THE USER. THE DEVICE WAS SERVICES AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER SKIN GRAFT MESHER NEEDED SERVICING. DURING DEVICE EVALUATION, IT WAS OBSERVED THAT THE COMB WAS BENT. THERE WAS NO PATIENT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134996 ZIMMER SKIN GRAFT MESHER COMPLEX ZIMMER SKIN GRAFT MESHER COMPLEX GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1