BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2926508 · Received January 16, 2013

    Report

    Report Number
    1526350-2013-00026
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(4) 2002, US AND (B)(4) 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 EVALUATION. THE SVC RECORD INDICATES THAT THE DEVICE IS 8 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2007. INSPECTION OF THE DEVICE DETERMINED THE SIDE PLATES, COMB, ROLLER, HANDLE, AND CARRIER GUIDE WERE DAMAGED. PRIOR TO REPAIR, THE DEVICE WAS DETERMINED TO BE OUT OF CALIBRATION ON THE RIGHT AND LEFT SIDE. 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 FEEDING THE GRAFT THROUGH AND THE GRAFT WAS BINDING. ADD'L CLINICAL FOLLOW UP WITH THE HOSP INDICATED THAT THE MESHER HAD NOT BEEN ABLE TO PERFORATE THE DONOR TISSUE. THERE WAS NO ADD'L HARVEST, AS THE TISSUE WAS REMOVED FROM THE MESHER AND MANUALLY PERFORATED FOR THE PLANNED WOUND COVERAGE. IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT SURGICAL TIME INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23580 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1