BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7855581 · Received September 7, 2018

    Report

    Report Number
    0001526350-2018-00860
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Report Date
    October 22, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI: (B)(4). ON AUGUST 14, 2018, IT WAS REPORTED THAT THE HAND PIECE OF THE DEVICE WAS LOSING POWER. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, 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. ZIMMER BIOMET AUSTRALIA HAS NOT PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER 112599 AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. PRODUCT REVIEW OF THE AIR DERMATOME BY ZIMMER BIOMET AUSTRALIA ON AUGUST 14, 2018 REVEALED THAT THERE WAS SIDE PLAY FOUND IN THE DEPTH BAR. PRODUCT REVIEW OF THE AIR DERMATOME BY ZIMMER BIOMET TAIWAN ON SEPTEMBER 7, 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATION AT ALL SETTINGS. THE MOTOR SPEED WAS BELOW SPECIFICATION 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 TAIWAN ON SEPTEMBER 12, 2018 WHICH INCLUDED REPLACEMENT OF THE MOTOR, BEARINGS, O-RING, SEAL, AND RECIPROCATING ARM. AIR 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 IT WAS NOTED THAT THE MOTOR SPEED WAS BELOW SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW IT WAS NOTED MOTOR SPEED WAS BELOW SPECIFICATION. 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

    AIR DERMATOME HANDPIECE WAS LOSING POWER. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED BY ZIMMER BIOMET IN (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

    AIR DERMATOME HANDPIECE WAS LOSING POWER. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697966 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 63415151

    Patients

    Seq Age Sex Outcome Treatment
    1