BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 8699746 · Received June 14, 2019

    Report

    Report Number
    0001526350-2019-00485
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 17, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT CODE IS DAMAGED HANDLE. REPORTED ISSUE: THE CUSTOMER SENT A PHOTO OF TWO SAMPLES REALIZED DURING A SURGERY TO REPORT A DEFECT. THE ONE ON THE TOP HAS BEEN REALIZED MANUALLY AND THE ONE ON THE BOTTOM HAS BEEN MADE WITH THE DERMACARRIER PLATE. THE ONE REALIZED WITH THE PLATE IS TEARED. THE SALES REPRESENTATIVE WENT TO CUSTOMER TO KNOW WHAT WAS THE PROBLEM. IT APPEARS THAT IT IS A CUTTER OF THE MESHGRAFT 00-2195-000-00 THAT IS DEFECTIVE AND NOT THE DEMARCARRIER USED. AN ADDITIONAL SKIN GRAFT WAS REQUIRED FROM THE PATIENT. THERE WAS A DELAY OF 45 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. DHR AND REPAIR HISTORY REVIEW: 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/FLEXTRONICS HAS NOT PREVIOUSLY REPAIRED/EVALUATED MESHGRAFT II SERIAL NUMBER (B)(6) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. TECHNICAL REVIEW AND PHYSICAL EXAMINATION: ON (B)(6) 2019, IT WAS REPORTED THAT THE CUSTOMER SENT A PHOTO OF TWO SAMPLES REALIZED DURING A SURGERY TO REPORT A DEFECT. THE ONE ON THE TOP HAS BEEN REALIZED MANUALLY AND THE ONE ON THE BOTTOM HAS BEEN MADE WITH THE DERMACARRIER PLATE. THE ONE REALIZED WITH THE PLATE IS TEARED. THE SALES REPRESENTATIVE WENT TO CUSTOMER TO KNOW WHAT WAS THE PROBLEM. IT APPEARS THAT IT IS A CUTTER OF THE MESHGRAFT 00-2195-000-00 THAT IS DEFECTIVE AND NOT THE DEMARCARRIER USED. THE CUSTOMER RETURNED A MESHGRAFT II DEVICE, SERIAL NUMBER (B)(6), FOR EVALUATION. PRODUCT REVIEW OF THE MESHGRAFT II BY FLEXTRONICS ON JULY 4, 2019 REVEALED THAT THE CALIBRATION WAS WITHIN SPECIFICATIONS AND THE DEVICE PRODUCED A PASSING SAMPLE MESH. THE HANDLE WAS DAMAGED AND NEEDED REPLACED. THE RATCHET FUNCTIONED AS INTENDED. REPAIR OF THE MESHGRAFT II WAS PERFORMED BY FLEXTRONICS ON JULY 8, 2019 WHICH INCLUDED REPLACEMENT OF THE HANDLE. MESHGRAFT II, SERIAL NUMBER (B)(6), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. RMA NUMBER 1756. PROBABLE CAUSE/ROOT CAUSE: THE RETURNED PRODUCT INVESTIGATION DID NOT CONFIRM THE REPORTED EVENT AS THE 00219500000 PRODUCED A PASSING MESH. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS COMPLAINT WILL BE TRACKED AND TRENDED. COMPLAINT TRENDING PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SKIN GRAFT THAT WAS OBTAINED USING THE MESHGRAFT CUTTER HAD BEEN TORN. THE EVENT OCCURRED DURING SURGERY AND THERE WAS A DELAY OF 45 MINUTES DURING THE PROCEDURE. AN ADDITIONAL UNPLANNED SKIN GRAFT WAS REQUIRED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493330 MESHGRAFT II COMPLETE SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. 64092523

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other