BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8865852 · Received August 6, 2019

    Report

    Report Number
    0001526350-2019-00623
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 19, 2019
    Report Date
    October 8, 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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D4: UDI #: (B)(4). DHR REVIEW: 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. DEVICE EVALUATIONS RESULTS/INVESTIGATION FINDINGS: PRODUCT REVIEW OF THE AIR DERMATOME ON AUGUST 5, 2019 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY. THE MOTOR SPEED WAS BELOW SPECIFICATIONS AND THE CONTROL BAR WAS IN THE CORRECT POSITION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON AUGUST 5, 2019 WHICH INCLUDED REPLACEMENT OF THE SPRING SEAL, O-RING, SCREWS, MOTOR, BEARINGS, BALL PLUNGER, DIE CAST LEVER, SEMI-CIRCLE BEARINGS, AND VESPEL BEARINGS. AIR DERMATOME, SERIAL NUMBER 113509, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. PROBABLE CAUSE/ROOT CAUSE: ALTHOUGH THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT CAUSED THE UNIT TO NOT CUT PROPERLY. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THAT THERE ARE NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS NOT CUTTING EVENLY. THERE WAS NO HARM AND NO DELAY REPORTED .THE EVENT OCCURRED DURING TESTING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659404 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 63962171

    Patients

    Seq Age Sex Outcome Treatment
    1