BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 5360836 · Received January 12, 2016

    Report

    Report Number
    0001526350-2016-00003
    Event Type
    Injury
    Date Received
    January 12, 2016
    Date of Event
    December 1, 2015
    Report Date
    March 10, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS MANUFACTURED ON 8/21/1987 AND HAS NO REPAIR HISTORY AT ZIMMER BIOMET SURGICAL SINCE JULY OF 2011. INVESTIGATION REVEALED THE SIDE PLATES WERE LOOSE AND THE SCREWS WERE SWITCHED IN THE WRONG POSITIONS. THERE WERE CHIPS IN THE CUTTER BLADES AND THE ROLLER WAS WORN. PRIOR TO REPAIR, THE TEST MESH PASSED. THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT SIDE AND ON THE RIGHT SIDE AND THE SIDE TO SIDE CALIBRATION. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE ROLLER, CUTTER, SCREWS, SIDE PLATES, SLIDING PIN AND SPRING. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING; HOWEVER, THE LACK OF CALIBRATION OF THE DEVICE, WHICH WAS MOST LIKELY DUE TO LACK OF PREVENTATIVE MAINTENANCE AND THE USE OF THE DEVICE 18 YEARS PAST THE USEFUL LIFE MOST LIKELY LED TO THE REPORTED EVENT. 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. RECOMMENDED ACTIONS: RECOMMENDED ACTIONS FROM ¿MESHGRAFT¿ II TISSUE EXPANSION SYSTEM INSTRUCTION MANUAL¿ 06001810593 REV. 02-11 TO AVOID SERIOUS INJURY TO THE PATIENT AND OPERATING STAFF WHILE USING THE MESHGRAFT II TISSUE EXPANSION SYSTEM, THE USER MUST BE THOROUGHLY FAMILIAR WITH ITS FUNCTION, APPLICATION, AND INSTRUCTIONS FOR USE. THE MESHGRAFT II TISSUE EXPANSION SYSTEM SHOULD BE INSPECTED PRIOR TO EACH USE. VISUALLY INSPECT FOR DAMAGE AND/OR WEAR. CHECK THE ACTION OF MOVING PARTS TO ENSURE SMOOTH OPERATION THROUGHOUT THE INTENDED RANGE OF MOTION. 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. NOTE: IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, DO NOT 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. PLEASE CONTACT YOUR ZIMMER SALES REPRESENTATIVE REGARDING REPLACEMENT OPTIONS. NO RECOMMENDED ACTIONS AT THIS TIME. IF THE PROBLEM PERSISTS, IT IS RECOMMENDED THAT THE CUSTOMER RETURN ANY ASSOCIATED PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE FAILED TO OPERATE CORRECTLY. ADDITIONAL CLINICAL INFORMATION DETERMINED THAT THE REPORTED ISSUE OCCURRED DURING SURGERY WHILE TRYING TO MESH THE GRAFT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORT AND THERE WAS NO IMPACT/DAMAGE TO GRAFT HARVEST. HOWEVER, THEY HAD TO RETRIEVE A SECOND GRAFT TO COVER THE DEFECT BECAUSE THEY COULD NOT MESH THE FIRST GRAFT TO STRETCH OVER THE DEFECT. THE SURGERY WAS COMPLETED USING AN ALTERNATE DEVICE WITH A DELAY OF ABOUT 15 TO 20 MINUTES, WHILE THE PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19409 MESHGRAFT II COMPLETE MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL, INC. NA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1