BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 8025395 · Received October 31, 2018

    Report

    Report Number
    0001954182-2018-00069
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 31, 2018
    Manufacturer
    DORNOCH
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ON (B)(4) 2018, IT WAS REPORTED THAT THERE WAS A BARE WIRE DUE TO FREQUENT USE OF THE DEVICE. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR AND PREVIOUS REPAIR REPORT REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER (B)(4) ONE TIME AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS JUNE 28, 2018 WHERE IT WAS REPORTED THAT THE DEVICE WAS EXPERIENCING A MALFUNCTION AND THE BEARINGS, SPRING SEAL, MOTOR, PLUG HARNESS ASSEMBLY, SEAL/STRAIN RELIEF, AND SWITCH WERE REPLACED. THIS IS NOT A RELATED ISSUE. PRODUCT REVIEW OF THE ELECTRIC DERMATOME BY MEDICREA ON OCTOBER 8, 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY. THE MOTOR SPEED WAS OUT OF SPECIFICATIONS ON THE HIGH SIDE AND THE CONTROL BAR WAS IN THE CORRECT POSITION. IT WAS ALSO NOTED THAT THE POWER CABLE WAS NOTCHED. THE CUSTOMER DID NOT RETURN A POWER SUPPLY FOR EVALUATION. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY MEDICREA ON OCTOBER 22, 2018 WHICH INCLUDED REPLACEMENT OF THE BEARINGS, SPRING SEAL, PLUG HARNESS ASSEMBLY, SEAL/STRAIN RELIEF, AND THICKNESS CONTROL SHAFT. ELECTRIC DERMATOME, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE POWER CABLE WAS NOTCHED. 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 POWER CABLE WAS NOTCHED. 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 BEFORE SURGERY, THERE WAS A BARE WIRE DUE TO FREQUENT USE OF THE DEVICE. THERE WAS NO PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862980 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD DORNOCH 63526314

    Patients

    Seq Age Sex Outcome Treatment
    1