BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 9575230 · Received January 10, 2020

    Report

    Report Number
    0001526350-2020-00041
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Report Date
    March 31, 2020
    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
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD AND PREVIOUS REPAIR RECORD FOR ZIMMER ELECTRIC DERMATOME SERIAL NUMBER 203106 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 (B)(6) 2019, IT WAS REPORTED THAT A DERMATOME STOPPED WORKING. THE CUSTOMER RETURNED A ZIMMER ELECTRIC DERMATOME SERIAL NUMBER (B)(6) FOR EVALUATION. EVALUATION OF THE DEVICE ON 8 JANUARY 2020 FOUND THAT THE DERMATOME WAS MISSING ITS WIDTHPLATE SCREWS, WOULD NOT POWER ON, AND HAD A CORRODED MOTOR. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE CONTROL BAR WAS OUT OF POSITION, AND THE DEVICE WAS OUT OF CALIBRATION AT THE ZERO SETTING. REPAIR OF THE DERMATOME OCCURRED ON (B)(6) 2020 AND INVOLVED REPLACING THE MOTOR, POWER SWITCH, THE MISSING WIDTHPLATE SCREWS AND THE NEEDLE BEARING AS WELL AS RECALIBRATING THE DEVICE AND MOVING THE CONTROL BAR BACK TO ITS PROPER POSITION. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED, THEN RETURNED THE DEVICE TO THE CUSTOMER WITHOUT FURTHER INCIDENT. WHILE THE SERVICE TECHNICIAN FOUND THAT THE MOTOR WAS CORRODED, WHICH CAN PREVENT THE MOTOR FROM MOVING AS INTENDED AND THEREFORE CAUSE THE MOTOR TO RUN BELOW MOTOR SPEED SPECIFICATIONS, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE CORROSION. 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 FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DERMATOME STOPPED WORKING DURING SURGERY. THERE WAS NO HARM AND NO DELAY. ANOTHER DERMATOME WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS WERE REPORTED AS RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-(B)(4). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. REPORT SOURCE - FOREIGN - (B)(6).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DERMATOME STOPPED WORKING DURING SURGERY. NO HARM OR DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39664 HANDPIECE, ELECTRIC DERMATOME DERNATOME GFD ZIMMER SURGICAL, INC. N/A 60604747

    Patients

    Seq Age Sex Outcome Treatment
    1