BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 5011809 · Received August 18, 2015

    Report

    Report Number
    1526350-2015-00151
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    February 1, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ZIMMERBIOMET SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED ON 01/20/1989 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL SINCE JULY 2011. INVESTIGATION REVEALED THE CUTTER AND ROLLER WERE DULL. IT WAS ALSO NOTED THAT THE HANDLE AND SCREWS WERE DAMAGED. PRIOR TO REPAIR, THE DEVICE PRODUCED AN ACCEPTABLE TEST MESH; HOWEVER, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE ROLLER, CUTTER, HANDLE, SCREWS, RATCHET SPRING AND SLIDING PIN. THE REPORTED EVENT WAS NOT REPRODUCED DURING TESTING; HOWEVER, THE LACK OF CALIBRATION OF THE DEVICE AND THE WEAR TO THE CUTTER BLADES CAN LEAD TO UNDESIRABLE MESH. PER THE INSTRUCTIONS FOR USE, "THE MESHGRAFT II TISSUE EXPANSION SYSTEM SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY." ADDITIONALLY, PER THE INSTRUCTIONS FOR USE, "THE EXPECTED LONGEVITY OF THE MESHGRAFT II TISSUE EXPANSION SYSTEM IS TEN YEARS. ZIMMER RECOMMENDS THAT UNITS OVER THIS AGE SHOULD BE REPLACED BECAUSE THEY HAVE EXCEEDED THEIR NORMAL USEFUL LIFE." THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. ADDITIONAL CLINICAL FOLLOW UP DETERMINED THAT THE ISSUE OCCURRED DURING A SURGICAL PROCEDURE THAT RESULTED IN HARM/INJURY TO THE PATIENT. IT WAS STATED THAT DURING THE PROCEDURE THE SURGEON HARVESTED TWO SKIN GRAFTS THAT WERE DEEMED UNUSABLE AND HAD TO BE DISCARDED. AN ALTERNATE DEVICE WAS RETRIEVED AND USED ON A THIRD SPECIMEN THAT WAS ABLE TO BE USED TO COMPLETE THE SURGERY. THERE WAS A DELAY OF AN UNKNOWN LENGTH TO THE PROCEDURE WHILE THE PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546082 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMERBIOMET SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1