BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 3748302 · Received January 24, 2014

    Report

    Report Number
    1526350-2014-00046
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, US AND (B)(6) 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 WER 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 8/16/1979 AND WAS LAST REPAIRED ON 9/28/2007. EVALUATION OF THE DEVICE DID NOT REPRODUCE THE CUSTOMER'S REPORTED EVENT DURING TESTING. IT WAS NOTED THAT THE RATCHET WAS MISSING A SET SCREW AND THERE WAS WEAR TO THE CUTTER, ROLLER AND SIDE PLATES. PRIOR TO REPAIR, A TEST MESH PASSED, BUT THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ON BOTH SIDES. CUSTOMER DID NOT RETURN ANY ASSOCIATED CARRIERS FOR INVESTIGATION. THE DEVICE WAS PREVIOUSLY RETURNED TO ZIMMER SURGICAL FOR REPAIR SEVEN YEARS AGO. THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED; HOWEVER, THE LACK OF CALIBRATION AND WEAR TO THE CUTTER AND ROLLER COULD CAUSE THE CUSTOMER'S REPORTED EVENT WHEN TRYING TO MESH SKIN. LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE LACK OF CALIBRATION AND WEAR TO THE CUTTER AND ROLLER. ADDITIONALLY, PER INSTRUCTIONS FOR USE, THE DEVICE HAS EXCEEDED ITS NORMAL USEFUL LIFE BY 25 YEARS, WHICH COULD HAVE DECREASED THE ACCURACY OF THE DEVICE AND CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER MESHGRAFT II WAS NOT PERFORATING SKIN IN MULTIPLE PLACES. 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
    55718 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1