BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 8019407 · Received October 30, 2018

    Report

    Report Number
    0001526350-2018-00978
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    November 28, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). D4: (B)(4). ON OCTOBER 5, 2018, IT WAS REPORTED THAT THE DEVICE DID NOT CUT THE SKIN COMPLETELY. THE SKIN HAD TO BE CUT MANUALLY BY THE DOCTOR. 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 VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE MESHGRAFT II BY MEDICREA ON NOVEMBER 12, 2018 REVEALED THAT THE CUTTER AND THE ROLLER HAD RUSTY STAINS AND WERE DAMAGED. REPAIR OF THE MESHGRAFT II WAS PERFORMED BY MEDICREA ON NOVEMBER 23, 2018 WHICH INCLUDED REPLACEMENT OF THE CUTTER AND ROLLER. MESHGRAFT II, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE CUTTER AND THE ROLLER HAD RUSTY STAINS AND WERE DAMAGED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE CUTTER AND THE ROLLER HAD RUSTY STAINS AND WERE DAMAGED. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. 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 · 0

    IT WAS REPORTED THAT THE DEVICE DOES NOT CUT THE SKIN COMPLETELY, THE SKIN WAS CUT BY THE DOCTOR BY HAND. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE DOESN´T CUT THE SKIN COMPLETELY. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859804 MESHGRAFT II COMPLETE EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 63924232

    Patients

    Seq Age Sex Outcome Treatment
    1