BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 7561157 · Received June 1, 2018

    Report

    Report Number
    0001526350-2018-00525
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 24, 2018
    Report Date
    July 16, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ON MAY 25, 2018, IT WAS REPORTED THAT THE DEVICE STOPPED DURING TESTING PRIOR TO SURGERY. THERE WAS A DEFECTIVE CONNECTOR AND THE HANDPIECE BLOCKS. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A POWER SUPPLY, SERIAL NUMBER (B)(4), 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 204657 AS DOCUMENTED IN THE VDOC SERVICE PORTAL. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME POWER SUPPLY SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE ELECTRIC DERMATOME BY MEDICREA ON JUNE 7, 2018 REVEALED THAT THE MOTOR WAS DEFECTIVE; THERE WAS NO MORE TORQUE. THE LEVER WAS ALSO DEFECTIVE. THE POWER SUPPLY, SERIAL NUMBER (B)(4), TESTED OKAY. PRIOR TO REPAIR, THE DEVICE DID NOT OPERATE AND WAS OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT THE ZERO THICKNESS SETTING. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY MEDICREA ON JULY 3, 2018 WHICH INCLUDED REPLACEMENT OF THE BALL BEARING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARING, VESPEL SLEEVE BEARING, MOTOR, LEVER AND BALL PLUNGER. 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 AND LEVER WERE DEFECTIVE. 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 AND LEVER WERE DEFECTIVE. 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.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED DURING THE TEST OF THE OPERATING ROOM OPENING BEFORE SURGERY. THERE WAS A DEFECTIVE CONNECTOR AND THE HANDPIECE BLOCKS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403836 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 61896868

    Patients

    Seq Age Sex Outcome Treatment
    1