BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3831821 · Received March 6, 2014

    Report

    Report Number
    1526350-2014-00155
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 7, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 10/26/2011 AND WAS LAST REPAIRED ON 03/16/2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE RATCHET WAS STUCK TO THE ROLLER. WHEN THE RATCHET WAS REMOVED, THE RATCHET GEAR DISPLAYED NICKS AND GALLING. THE RIGHT END OF THE ROLLER WAS EXCESSIVELY NICKED AND GALLED. ADDITIONALLY THE RIGHT LATCHING PIN DID NOT LOCK, THE SIDE PLATES WERE WORN AND THAT THE COMB, ROLLER AND ROLLER GEAR. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE PERFORMED AS A RESULT OF THE DAMAGED ROLLER. THE CAUSE OF THE REPORTED ISSUE WAS IMPROPER HANDLING THAT CAUSED THE DAMAGE TO THE ROLLER AND RATCHET GEAR. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER HANDLE WAS BROKEN. ADDITIONAL CLINICAL FOLLOW UP INDICATED THAT THERE WAS NO PATIENT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135714 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1