BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 3533883 · Received December 18, 2013

    Report

    Report Number
    1526350-2013-00767
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 21, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MESHGRAFT II. 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 08/23/1974 AND WAS LAST REPAIRED ON (B)(6) 2006 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE ROLLER, CUTTER AND SIDE PLATES WERE WORN. PRIOR TO REPAIR, A TEST MESH PASSED; HOWEVER, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT AND RIGHT SIDES, AND SIDE TO SIDE CALIBRATION. CUSTOMER DID NOT RETURN ANY ASSOCIATED CARRIERS FOR INVESTIGATION. PER INSTRUCTIONS FOR USE, THE "DERMACARRIER II CARRIER SHOULD BE USED GROOVED SIDE UP AND THE SKIN MUST BE PLACED ON THIS SIDE OF THE CARRIER. IF THE SKIN IS PLACED ON THE SMOOTH SIDE OF THE DERMACARRIER II SKIN GRAFT CARRIER (UPSIDE DOWN), THE GRAFT WILL BE SHREDDED INTO LONG STRIPS AND WILL BE UNUSABLE." CAUSE OF THE CUSTOMER'S REPORTED EVENT WAS MOST LIKELY DUE TO IMPROPER PLACEMENT OF THE SKIN ONTO THE CARRIER. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE ZIMMER MESHGRAFT II THE "SKIN CAME OUT LIKE SPAGHETTI". NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661263 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1