BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3338896 · Received August 22, 2013

    Report

    Report Number
    1526350-2013-00467
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PATIENT 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 MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 09/20/1993 AND WAS LAST REPAIRED ON 07/02/2001 FOR A BENT COMB. EVALUATION OF THE DEVICE VERIFIED THE COMB TO BE DAMAGED. ADDITIONALLY, THE RIGHT END OF THE ROLLER WAS GNARLED AND GALLED. WEAR TO THE SIDE PLATES WA ALSO OBSERVED. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK WAS NOT PERFORMED DUE TO THE DAMAGED COMB. 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 HAD A BENT GUARD. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE REPORTED ISSUE WAS OBSERVED IN STERILE PROCESSING, PRIOR TO PUTTING THE DEVICE TO INVENTORY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408307 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1