BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 9328731 · Received November 15, 2019

    Report

    Report Number
    0001526350-2019-01021
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). 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. PRODUCT REVIEW OF THE ELECTRIC DERMATOME ON (B)(6) 2019 REVEALED THAT THE POWER CORD WAS DAMAGED AND THE MOTOR WAS RUNNING ERRATICALLY. THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY AND THE CONTROL BAR WAS IN THE CORRECT POSITION. THE CUSTOMER DID NOT RETURN A POWER SUPPLY FOR EVALUATION. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6) 2019 WHICH INCLUDED REPLACEMENT OF THE SEAL/STRAIN RELIEF, O-RING, END CAP, PLUG HARNESS ASSEMBLY, SWITCH, MOTOR, SEMI-CIRCLE BEARINGS, VESPEL BEARINGS, RECIPROCATING ARM, NEEDLE BEARING, BALL BEARINGS, AND SPRING SEAL. ELECTRIC DERMATOME, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE ELECTRIC DERMATOME HAD A DAMAGED POWER CORD, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT ACTUALLY CAUSED THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE SEAL/STRAIN RELIEF, O-RING, END CAP, PLUG HARNESS ASSEMBLY, SWITCH, MOTOR, SEMI-CIRCLE BEARINGS, VESPEL BEARINGS, RECIPROCATING ARM, NEEDLE BEARING, BALL BEARINGS, AND SPRING SEAL WERE REPLACED. 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

    DURING TESTING, IT WAS REPORTED THAT THE CORD ON THE HANDPIECE IS DAMAGED. DURING INVESTIGATION, IT WAS DISCOVERED THAT THE MOTOR WAS ALSO RUNNING ERRATICALLY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124387 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 62904088

    Patients

    Seq Age Sex Outcome Treatment
    1