BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2445582 · Received February 6, 2012

    Report

    Report Number
    1526350-2012-00023
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    December 1, 2011
    Report Date
    February 2, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE NOT RETURNED FOR EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 5 YEARS OLD AND HAS NOT PREVIOUSLY BEEN RETURNED TO ZIMMER FOR SERVICE. UNABLE TO DETERMINE A CAUSE OF THE REPORTED COMPLAINT, HOWEVER, THIS DEVICE IS OVERDUE FOR PREVENTATIVE MAINTENANCE. CLINICAL F/U INDICATED THE CUSTOMER REUSES DERMACARRIERS, AND THAT THE GRAFT WAS PERFORATED ON ONE HALF OF THE GRAFT AND THE OTHER HALF WAS NOT PERFORATED. THE ZIMMER SKIN GRAFT MESHER INSTRUCTION MANUAL STATES: THE CARRIERS ARE INTENDED FOR SINGLE USE ONLY. REUSE MAY RESULT IN AN UNSATISFACTORY MESH PATTERN. IT IS LIKELY THIS DEVICE HAS EXCESSIVE WEAR AND TEAR DUE TO A LACK OF ZIMMER SERVICE FOR 5 YEARS, HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVAL. THIS IS A RE-USABLE DEVICE, SUBJECT TO NORMAL WEAR AND TEAR, AND HAS NOT BEEN RETURNED TO ZIMMER FOR SERVICE OR PREVENTATIVE MAINTENANCE SINCE ITS PURCHASE IN 2007. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS NOT GRAFTING. ADD'L CLINICAL F/U WITH THE HOSP INDICATED THAT THERE WAS NO ADD'L DONOR HARVEST REQUIRED. THE GRAFT WAS DESCRIBED TO HAVE BEEN ADEQUATELY MESHED ON ONE SIDE (LENGTHWISE) AND INCOMPLETELY MESHED ON THE OTHER SIDE. A SURGICAL BLADE WAS USED TO COMPLETE THE DESIRED PERFORATIONS AND THE INITIAL GRAFT WAS USED TO COMPLETE THE PLANNED WOUND COVERAGE. THE SURGICAL TIME WAS REPORTED TO HAVE BEEN INCREASED BY 30 MINUTES. IT WAS ALSO REPORTED THAT A DERMACARRIER IS USED MORE THAN ONCE. THE SALES TEAM IN (B)(4) IS AWARE OF THIS ISSUE; THE CUSTOMER REUSES DERMACARRIERS DUE TO COST ALTHOUGH, THE INSTRUCTION FOR USE AND LABELING INDICATES THIS IS A SINGLE USE PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 DERMACARRIER