BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 9207378 · Received October 18, 2019

    Report

    Report Number
    0001526350-2019-00909
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Report Date
    October 18, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD AND PREVIOUS REPAIR RECORD FOR ZIMMER ELECTRIC DERMATOME 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 DEVICE. THE RECORD REVIEWS FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE EVALUATION AND REPAIR. ON 5 JULY 2019, IT WAS REPORTED THAT A DERMATOME WAS NOT WORKING. THE CUSTOMER RETURNED A ZIMMER ELECTRIC DERMATOME SERIAL NUMBER 203570 FOR EVALUATION. EVALUATION OF THE DEVICE ON 19 JULY 2019 NOTED THAT THE DERMATOME WAS OUT OF CALIBRATION AT THE ZERO SETTING AND THAT THE CONTROL BAR DID NOT SIT FLUSH TO THE MASTER BLADE DURING TESTING. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE CABLE WAS DAMAGED AND THAT THE MOTOR DID NOT RUN PROPERLY. IT WAS RECOMMENDED TO REPLACE THE NEEDLE BEARING. REPAIR OF THE DERMATOME OCCURRED ON 25 JULY 2019 AND INVOLVED REPLACING THE NEEDLE BEARING AND PLUG HARNESS ASSEMBLY AS WELL AS RECALIBRATING THE DEVICE. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DERMATOME WAS FUNCTIONING AS INTENDED, THEN RETURNED THE DEVICE TO THE CUSTOMER WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. WHILE THE SERVICE TECHNICIAN FOUND THAT THE DERMATOME HAD A DAMAGED CABLE, THAT THE DEVICE HAD A DEFECTIVE NEEDLE BEARING, AND THAT THE CONTROL BAR DID NOT SIT FLUSH WITH THE MASTER BLADE DURING TESTING, ALL FAILURES THAT WOULD RESULT IN THE DERMATOME NOT FUNCTIONING AS INTENDED, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE FAILURE WITH THE DEVICE. AS SUCH, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THAT THERE ARE NO FURTHER ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED PER COMPLAINT TRENDING PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SENT BACK FOR A REPAIR AS IT WAS NOT WORKING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003759 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 60970726

    Patients

    Seq Age Sex Outcome Treatment
    1