BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8064304 · Received November 13, 2018

    Report

    Report Number
    0001526350-2018-00506
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Report Date
    November 13, 2018
    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
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). CONCLUSION SUMMARY: ON JUNE 23, 2017, IT WAS REPORTED THAT THE MESHER DOES NOT WORK PROPERLY. THE CUSTOMER RETURNED A SKIN GRAFT MESHER 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 SKIN GRAFT MESHER SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE SKIN GRAFT MESHER BY MEDICREA ON JULY 10, 2017 REVEALED THAT THE ROLLER GEAR AND ROLLER WERE DAMAGED. THE SET SCREW IN THE RATCHET HANDLE GEAR WAS MISSING. THE SAMPLE GRAFT DID NOT PASS THE MESH TEST. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY MEDICREA ON AUGUST 10, 2017 WHICH INCLUDED REPLACEMENT OF THE BOTTOM ROLLER, ROLLER GEAR, BEARING WASHER AND RATCHET HANDLE SET SCREW. SKIN GRAFT MESHER, 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 ROLLER GEAR AND ROLLER WERE DAMAGED. ALSO THE SET SCREW IN THE RATCHET HANDLE GEAR WAS MISSING. 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 ROLLER GEAR AND ROLLER WERE DAMAGED. ALSO THE SET SCREW IN THE RATCHET HANDLE GEAR WAS MISSING. 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. NO FURTHER CONCLUSIONS CAN BE DRAWN FROM THE COMPLAINT HISTORY REVIEW THAT WARRANTS FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MESHER DOES NOT WORK PROPERLY. IT WAS RETURNED TO MEDICREA IN (B)(4). PRODUCT REVIEW FOUND THAT THE SAMPLE GRAFT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905064 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 60676162

    Patients

    Seq Age Sex Outcome Treatment
    1