BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II INSTRUMENT ONLY

    MDR report key: 7811265 · Received August 23, 2018

    Report

    Report Number
    0001526350-2018-00824
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PPREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE HAD SOME GRINDING AND NEEDED MAINTENANCE. THE CUSTOMER RETURNED A MESHGRAFT II DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCE'S, 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 (B)(6) 2018 REVEALED THAT THE INCOMING TEST FAILED. THE CALIBRATION AND CUTTER WERE DEFECTIVE. THE HANDLE WAS WORN AND CORRODED. REPAIR OF THE MESHGRAFT II HAS NOT YET BEEN PERFORMED BY MEDICREA AS THE QUOTE FOR SERVICE IS STILL PENDING CUSTOMER APPROVAL. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE INCOMING TEST FAILED. THE CALIBRATION AND CUTTER WERE DEFECTIVE. 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 INCOMING TEST FAILED. THE CALIBRATION AND CUTTER WERE DEFECTIVE. 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 · 1

    IT WAS REPORTED THAT THE DEVICE HAD SOME GRINDING AND NEEDED MAINTENANCE. REQUESTING FOR SHARPEN AND REPAIR. THE ISSUE HAS BEEN NOTICED DURING INSPECTION AT THE HOSPITAL STERILIZATION AND DISINFECTION DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. PRODUCT INVESTIGATION FOUND THAT THE DEVICE DID NOT PASS INCOMING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650028 MESHGRAFT II INSTRUMENT ONLY EXPANDER, SKIN GRAFT, SURGICAL FZW ZIMMER SURGICAL, INC. 61040382

    Patients

    Seq Age Sex Outcome Treatment
    1