BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8699768 · Received June 14, 2019

    Report

    Report Number
    0001526350-2019-00486
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 20, 2019
    Report Date
    August 13, 2019
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON MAY 29, 2019, IT WAS REPORTED THAT THE DEVICE HAD AN AIR LEAK FROM HAND PIECE. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(6), 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 SURGICAL HAS NOT PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(6) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. PRODUCT REVIEW OF THE AIR DERMATOME ON JUNE 4, 2019 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY. THE MOTOR SPEED WAS WITHIN SPECIFICATIONS AND THE CONTROL BAR WAS IN THE CORRECT POSITION. THE HEAD, CONTROL BAR, AND LEVER WERE VISIBILITY DAMAGED. THE CUSTOMER HOSE AND WIDTH PLATES WERE NOT RETURNED FOR EVALUATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON JUNE 4, 2019 WHICH INCLUDED REPLACEMENT OF THE MACHINED HEAD, NEEDLE BEARING, DIE CAST LEVER, SCREWS, BEARING SPACERS, RING GEAR, PLANETARY SPACER, POPPET, HINGE THROTTLE GASKET, THROTTLE, RECIPROCATING ARM, POPPET SPRING, O-RINGS, POPPET HOUSING, PLANETARY GEARS, ECCENTRIC SHAFT, BEARINGS, DOWEL PIN, MOTOR SLEEVE, MOTOR, SWIVEL, INTERNAL RETAINING RING, SPRING SEAL, FINE ADJUSTMENT CAMS, BALL PLUNGER, SPRING PIN, VESPEL BEARINGS, SEMICIRCLE BEARINGS, ADJUSTMENT CAMS, AND THICKNESS CONTROL SHAFT. AIR DERMATOME, SERIAL NUMBER 102581, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS NON-VERIFIABLE SINCE DURING THE PRODUCT REVIEW IT WAS NOTED THAT THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS. NO LEAK WAS NOTED DURING EVALUATION OR TESTING. 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 THAT THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS. NO LEAK WAS NOTED DURING EVALUATION OR TESTING. 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 AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN AIR LEAK FROM HAND PIECE. EVENT WAS DISCOVERED UPON CONNECTION IN OPERATING ROOM, THERE WAS NO HARM, NO DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493555 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 2700100

    Patients

    Seq Age Sex Outcome Treatment
    1