BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 9336649 · Received November 18, 2019

    Report

    Report Number
    0001526350-2019-01025
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 8, 2019
    Report Date
    January 13, 2020
    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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. D4 - UDI NO.: (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 AIR DERMATOME BY ZIMMER BIOMET CHINA ON OCTOBER 24, 2019 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT ALL SETTINGS. THE MOTOR SPEED WAS BELOW SPECIFICATIONS AND THE CONTROL BAR WAS IN THE CORRECT POSITION. THE CUSTOMER HOSE AND WIDTH PLATES WERE NOT RETURNED FOR EVALUATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET CHINA ON OCTOBER 24, 2019 WHICH INCLUDED REPLACEMENT OF THE VESPEL BEARINGS, SEMI-CIRCLE BEARINGS, SCREWS, MOTOR, RECIPROCATING ARM, NEEDLE BEARING, AND EXTERNAL E-RING. AIR DERMATOME, SERIAL NUMBER 112816, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE AIR DERMATOME HAD A MALFUNCTIONING MOTOR, 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 VESPEL BEARINGS, SEMI-CIRCLE BEARINGS, SCREWS, MOTOR, RECIPROCATING ARM, NEEDLE BEARING, AND EXTERNAL E-RING WAS 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 · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. FOREIGN: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE EQUIPMENT IT WAS DIFFICULT TO REMOVE THE SKIN DUE TO INSUFFICIENT POWER. THE EVENT OCCURRED BEFORE THE SURGERY. NO HARM OR DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131593 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 63415162

    Patients

    Seq Age Sex Outcome Treatment
    1