BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 9343624 · Received November 19, 2019

    Report

    Report Number
    0001526350-2019-01048
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL / FINAL REPORT BASED ON INFORMATION DISCOVERED DURING THE DEVICE EVALUATION. DHR 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. THE PRE-TEST CALIBRATION AND TEST CUT COULD NOT BE TAKEN DUE TO A BENT COMB. THE ROLLER, GEAR AND SIDE PLATES ALSO HAD VISIBLE DAMAGE. THE DEVICE WAS RECEIVED WITH CUTTERS 1.5-1 1204019, 2-1 1201066 AND 3-1112044. THE DEVICE WAS AN AGED REPAIR WITH CUSTOMER APPROVAL. THE SIDE PLATES, BUSHINGS, ROLLER, COMB, GEAR, CARRIER GUIDE, HANDLE, SHOULDER BOLTS AND WASHERS WERE REPLACED. THE RATCHET GEAR WAS REPLACED. THE CUTTERS 1.5-1 1204019, 2-1 1201066 AND 3-1112044 ALL PRODUCED PASSING CUTS. THE DEVICE WAS TESTED AND CALIBRATED. PROBABLE/ROOT CAUSE: WHILE THIS DEVICE WAS BROUGHT IN FOR PREVENTATIVE MAINTENANCE, IT WAS NOTED THAT IT REQUIRED REPAIR FOR ADDITIONAL DEFECTIVE COMPONENTS. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED WHAT LED TO THE DEFECTIVENESS OF THE REPLACED COMPONENTS. THEREFORE, BASED ON THE INFORMATION THAT WAS PROVIDED THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THIS INVESTIGATION DETERMINED THAT THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY REQUIRE ADDITIONAL ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIALLY THE COMPLAINT WAS FOUND THAT IT WAS PREVENTIVE MAINTENANCE. LATER IT WAS NOTICED THAT THE UNIT REQUIRED REPAIR. DURING INVESTIGATION, IT WAS DISCOVERED THAT THERE WAS A BENT COMB. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139402 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FWZ ZIMMER SURGICAL, INC. 31754300

    Patients

    Seq Age Sex Outcome Treatment
    1