BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8470827 · Received April 1, 2019

    Report

    Report Number
    0001526350-2019-00199
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION THE PREVIOUS REPAIR REPORT FOR ZIMMER SKIN GRAFT MESHER, SERIAL NUMBER (B)(4), WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED ZIMMER SKIN GRAFT MESHER, SERIAL NUMBER (B)(4), TWELVE TIMES. THE PREVIOUS REPAIR WAS FOR INCOMPLETE MESH ON 04 FEB 2019 IN WHICH THE COMB, ROLLER, AND ROLLER GEAR WERE REPLACED. THE REPLACED ROLLER GEAR WAS ASSOCIATED WITH THE CURRENT REPAIR. THUS, THE CURRENT REPAIR IS SIMILAR IN NATURE TO THE PREVIOUS REPAIR. ON 26 MAR 2019, IT WAS REPORTED FROM THE LIVING LEGACY FOUNDATION THAT A ZIMMER SKIN GRAFT MESHER WAS GIVING AN INCOMPLETE MESH. THE CUSTOMER RETURNED A ZIMMER SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND A 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), FOR EVALUATION. PRODUCT REVIEW OF THE ZIMMER SKIN GRAFT MESHER BY ZIMMER BIOMET SURGICAL ON 02 APR 2019 REVEALED THAT THE ROLLER GEAR WAS DAMAGED. THE CALIBRATION WAS IN SPECIFICATION AND THE TEST CUT SAMPLE PASSED. THE CUSTOMER ALSO RETURNED A 1.5:1 RATIO CUTTER WHICH FAILED INSPECTION AND A 2:1 RATIO CUTTER THAT PASSED INSPECTION. REPAIR OF THE ZIMMER SKIN GRAFT MESHER WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON 02 APR 2019 WHICH INCLUDED REPLACEMENT OF THE ROLLER GEAR. ZIMMER SKIN GRAFT MESHER, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. RGA NUMBER 6082220 DATED 26 MAR 2019. THE REPORTED EVENT CANNOT BE CONFIRMED BECAUSE THE DEVICE WAS IN CALIBRATION AND PRODUCED A PASSING TEST CUT UPON PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE DEVICE WAS IN CALIBRATION AND PRODUCED A PASSING TEST CUT UPON PRODUCT EVALUATION. IT WAS FOUND THE ONE OF THE CUTTERS WAS DAMAGED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT BUT IT IS UNKNOWN WITH THE INFORMATION PROVIDED. A SKIN GRAFT MESHER CUTTER MEMO WAS SENT TO THE CUSTOMER NOTIFYING THEM OF THE DAMAGED CUTTER AND RECOMMENDING THEM TO NO LONGER USE THE CUTTER AND PURCHASE A REPLACEMENT (SEE PAGE 3 OF SERIAL NUMBER 1512806 CURRENT REPAIR REPORT). THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE ROLLER GEAR WAS REPLACED. 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

    NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). DEVICE IS BEING RETURNED FOR EVALUATION. ONCE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ZIMMER SKIN GRAFT MESHER HAD AN INCOMPLETE MESH. THE EVENT OCCURRED ON A CADAVER, THEREFORE NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264169 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 63138572

    Patients

    Seq Age Sex Outcome Treatment
    1