BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3177370 · Received June 13, 2013

    Report

    Report Number
    1526350-2013-00318
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SVC RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 07/22/1994 AND WAS LAST REPAIRED ON 11/19/2004 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED THAT THE COMB WAS BENT. IT WAS ALSO OBSERVED THAT THE ROLLER, SIDE PLATES AND RATCHET WERE DAMAGED. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS. THE CUSTOMER DID NOT INCLUDE ANY CUTTERS FOR EVAL. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING AND LACK OF PREVENTIVE MAINTENANCE. 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 WORKING. ADDITIONAL CLINICAL F/U WITH THE HOSPITAL INDICATED THAT THE ISSUE OCCURRED DURING SURGERY, THERE WAS NO HARM TO THE PT AND NO INCREASE IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269164 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1