BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 8054764 · Received November 9, 2018

    Report

    Report Number
    0001526350-2018-01010
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Report Date
    December 14, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). (B)(6). THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2018, IT WAS REPORTED THAT DURING SURGERY, THE DEVICE FAILED TO MESH CORRECTLY. ACCORDING TO HOD THE MESHER HAS NOT BEEN WORKING PROPERLY SINCE DELIVERY OF THE UNIT HOWEVER WAS MUCH WORSE WITH A THICKER GRAFT. THE CUSTOMER RETURNED A MESHGRAFT II DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED MESHGRAFT II SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. PRODUCT REVIEW OF THE MESHGRAFT II BY MEDICREA ON (B)(6) 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS. THE SIDE PLATES AND HANDLE FAILED VISUAL INSPECTION. THE DEVICE PRODUCED A PASSING SAMPLE MESH. REPAIR OF THE MESHGRAFT II WAS PERFORMED BY MEDICREA ON (B)(6) 2018 WHICH INCLUDED REPLACEMENT OF THE SIDE PLATES AND HANDLE. MESHGRAFT II, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS NOT CONFIRMED SINCE DURING PRODUCT REVIEW THE DEVICE PRODUCED A PASSING SAMPLE MESH. THE ROOT CAUSE OF THE DEVICE NOT MESHING PROPERLY COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE DEVICE PRODUCED A PASSING SAMPLE MESH DURING PRODUCT REVIEW. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    ACCORDING TO HOD THE MESHER HAS NOT BEEN WORKING PROPERLY SINCE DELIVERY OF THE UNIT HOWEVER WAS MUCH WORSE WITH A THICKER GRAFT. THERE WAS NO DAMAGE TO THE MESHER. THIS COMPLAINT WAS CREATED FOR THE UNKNOWN TIMES IT MALFUNCTIONED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895414 MESHGRAFT II COMPLETE EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 64063477

    Patients

    Seq Age Sex Outcome Treatment
    1