BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 8070881 · Received November 14, 2018

    Report

    Report Number
    0001526350-2018-01038
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Report Date
    November 14, 2018
    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). ON (B)(6) 2017, IT WAS REPORTED THAT THE DEVICE HAD INTERMITTENT POWER. THE MOTOR WAS CORRODED AND THE CORD WAS DAMAGED. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A STERILIZATION CASE, SCREWDRIVER AND 1/2/3/4 WIDTH PLATES, FOR EVALUATION. 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. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE ELECTRIC DERMATOME BY MEDICREA ON (B)(6) 2017 REVEALED THAT THE MOTOR WAS CORRODED AND THE POWER CORD WAS DAMAGED. THE LEVER AND RECIPROCATING ARM WERE WORN. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY MEDICREA ON (B)(6) 2017 WHICH INCLUDED REPLACEMENT OF THE BALL BEARING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARING, VESPEL SLEEVE BEARING, MOTOR, LEVER, BALL PLUNGER, RECIPROCATING ARM, PLUG HARNESS AND SEAL/STRAIN RELIEF. 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 MOTOR WAS CORRODED AND THE POWER CORD WAS DAMAGED. 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 MOTOR WAS CORRODED AND THE POWER CORD WAS DAMAGED. 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 THE DEVICE HAD INTERMITTENT POWER, MOTOR WAS CORRODED AND THE CORD ALSO GOT DAMAGED. THE DEVICE WAS SENT TO MEDICREA FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908458 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63095204

    Patients

    Seq Age Sex Outcome Treatment
    1