BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3162377 · Received June 6, 2013

    Report

    Report Number
    1526350-2013-00299
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAFT MESHER. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 03/29/2001 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVAL OF THE DEVICE OBSERVED THAT THE COMB AND THE SIDE PLATES WERE DAMAGED. A TEST MESH AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. THE CUSTOMER DID NOT RETURN ANY CUTTERS FOR EVAL. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING. ACCORDING TO THE INSTRUCTIONS FOR USE, THE ZIMMER SKIN GRAFT MESHER SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. 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 FUNCTIONING PROPERLY AND HAD BENT PRONGS. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT THE COMB ON THE MESHER WAS BENT. THE REPORTED ISSUE WAS OBSERVED PRIOR TO SURGERY AND THERE WAS NO PT INJURY OR SURGICAL DELAY. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252586 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1