BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 3894235 · Received February 14, 2014

    Report

    Report Number
    1526350-2014-00086
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 16, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT 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 MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATED THAT THE DEVICE IS MANUFACTURED ON 06/06/2012 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVAL OF THE DEVICE OBSERVED WEAR TO THE ROLLER AND CUTTER. PRIOR TO REPAIR, A TEST MESH PASSED AND THE DEVICE WAS WITHIN CALIBRATION SPECS. CUSTOMER DID NOT RETURN A RATCHET OR ANY ASSOCIATED CARRIERS FOR EVAL. THE CUSTOMER'S REPORTED EVENT COULD NOT BE REPRODUCED DURING TESTING AND A CAUSE COULD NOT BE DETERMINED; HOWEVER, THE WEAR TO THE CUTTER COULD CAUSE THE DEVICE TO PRODUCE AN UNDESIRABLE MESH WHEN MESHING SKIN. IMPROPER HANDLING BY THE USER AND LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE WEAR TO THE CUTTER AND ROLLER. PER INSTRUCTIONS FOR USE, IT IS RECOMMENDED THAT THE DEVICE BE RETURNED FOR MAINTENANCE ANNUALLY. 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 CENTER OF THE BLADE WAS NOT CUTTING. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT. IF ADD'L INFO IS RECEIVED, A F/U MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98034 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1