BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 8159384 · Received December 13, 2018

    Report

    Report Number
    0001526350-2018-01100
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 24, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). CONCLUSION SUMMARY: ON NOVEMBER 16, 2018, IT WAS REPORTED THAT THE DERMATOME STOPPED AT THE MOMENT TO TAKE THE SKIN. 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 VDOC SERVICE PORTAL. THE LAST REPAIR WAS SEPTEMBER 18, 2017 WHERE IT WAS REPORTED THAT THE DEVICE WAS ALMOST IMPOSSIBLE TO DO AND THE BEARINGS, SPRING SEAL, VESPEL BEARINGS, MOTOR, PLUG HARNESS ASSEMBLY, SEAL/STRAIN RELIEF, SWITCH, CONTROL BAR, AND THICKNESS CONTROL LEVER WERE REPLACED. THIS IS NOT A RELATED ISSUE. PRODUCT REVIEW OF THE ELECTRIC DERMATOME BY MEDICREA ON NOVEMBER 30, 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO, TEN, AND TWENTY SETTINGS. THE MOTOR DID NOT OPERATE 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 MEDICREA ON DECEMBER 5, 2018 WHICH INCLUDED REPLACEMENT OF THE BEARINGS, SPRING SEAL, VESPEL BEARINGS, MOTOR, PLUG HARNESS ASSEMBLY, SEAL/STRAIN RELIEF, AND CONTROL BAR. 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 DID NOT OPERATE. 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 DID NOT OPERATE. 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 · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON (B)(6) 2018, THE DERMATOME STOPPED AT THE MOMENT TO TAKE THE SKIN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002383 HANDPIECE, ELECTRIC DERMATOME DERMATOME FZW ZIMMER SURGICAL, INC. 62904087

    Patients

    Seq Age Sex Outcome Treatment
    1