BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II

    MDR report key: 6180545 · Received December 16, 2016

    Report

    Report Number
    0001526350-2016-00149
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    December 5, 2016
    Report Date
    January 2, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PPREAMEND
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ON (B)(6) 2016, IT WAS REPORTED THAT THE FIRST 2 GRAFTS CUT THE SKIN LIKE SPAGHETTI AND THE THIRD GRAFT GOT STUCK IN THE MESHER. THE DERMACARRIER WAS INSERTED WITH THE CORRECT SIDE UP. THERE WAS A FOURTH GRAFT THAT WAS NEEDED TO BE TAKEN WITHOUT USING THE MESHER. THE MESHER HAD NOT BEEN SERVICED FOR SOME TIME AND THE CUTTER WAS DAMAGED WHEN TRYING TO RETRIEVE THE GRAFT. THE CUSTOMER RETURNED A MESHGRAFT II DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE DHR ASSOCIATED WITH THIS SERIALIZED DEVICE WAS UNAVAILABLE FOR REVIEW AT THE TIME OF PROCESSING THIS COMPLAINT. ZIMMER BIOMET (B)(4) HAS NOT PREVIOUSLY REPAIRED/EVALUATED MESHGRAFT II SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. INITIAL QA INSPECTION OF THE MESHGRAFT II BY ZIMMER BIOMET (B)(6) ON (B)(6) 2016 REVEALED THAT THE PRE-TEST INSPECTION FAILED AS THE UNIT ARRIVED WITH THE TOP ASSEMBLY REMOVED. THE UNIT HAD OLDER STYLE SIDE PLATES AND THE CUTTER HAD VISUAL MARKS ON IT. THE HANDLE AND BOTTOM ROLLER WERE BOTH WORN AND NEEDED REPLACED. THE CALIBRATION WAS UNABLE TO BE CHECKED SINCE THE TOP ASSEMBLY WAS REMOVED FROM THE UNIT PRIOR TO IT REACHING THE REPAIR CENTER. THE MESHGRAFT II WAS NOT REPAIR AND IS TO BE DECOMMISSIONED AND NOT RETURNED TO THE CUSTOMER AS THE CUSTOMER IS BUYING TWO NEED UNITS INSTEAD OF REPAIRING THIS UNIT. IT WAS INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE INITIAL INSPECTION THE PRE-TEST FAILED. HOWEVER, IT WAS FOUND THAT THE UNIT HAD OLDER STYLE SIDE PLATES AND THE CUTTER HAD VISUAL MARKS ON IT. THE HANDLE AND BOTTOM ROLLER WERE BOTH WORN AND NEEDED REPLACED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO THE DAMAGED CUTTER AND THE WORN BOTTOM ROLLER. THE UNIT WAS NOT REPAIRED AS THE CUSTOMER BUYING NEW UNITS. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. MESHGRAFT II, SERIAL NUMBER (B)(4), WAS TESTED AND THEN DECOMMISSIONED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT FIRST TWO GRAFTS TAKEN BY THE MESHER CUT THE SKIN LIKE SPAGHETTI. A THIRD GRAFT WAS TAKEN AND GOT STUCK IN THE MESHER. THEN, AN ADDITIONAL UNPLANNED FOURTH GRAFT WAS TAKEN WITHOUT USING THE MESHER. IT IS REPORTED THE MESHER HAS NOT BEEN SERVICED IN SOME TIME AND OLD. THE CUTTER WAS DAMAGED WHEN TRYING TO RETRIEVE THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831160 MESHGRAFT II MESHGRAFT II COMPLETE FZW ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other