BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8695002 · Received June 13, 2019

    Report

    Report Number
    0001526350-2019-00469
    Event Type
    Malfunction
    Date Received
    June 13, 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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON (B)(6) 2019, IT WAS REPORTED THAT THE AIR WAS NOT GETTING THROUGH THE DEVICE. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(6), 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. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(6) ONE TIME AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS MARCH 14, 2018 WHERE IT WAS REPORTED THAT THE BLADES ARE COMING LOOSE AND THE BEARINGS, SEAL AND RETAINING RING, MOTOR, POPPET ASSEMBLY, O-RING, MACHINED HEAD, AND CALIBRATION SHAFT WERE REPLACED. THIS IS NOT A RELATED ISSUE. PRODUCT REVIEW OF THE AIR DERMATOME ON JUNE 18, 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 CUSTOMER HOSE AND WIDTH PLATES WERE NOT RETURNED FOR EVALUATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON JUNE 18, 2019 WHICH INCLUDED REPLACEMENT OF THE VESPEL BEARINGS AND SEMICIRCLE BEARINGS. AIR DERMATOME, SERIAL NUMBER 111390, 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. 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. 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

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE CUSTOMER HAS INDICATED THAT THE DEVICE IS BEING 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 AIR WAS NOT GETTING THROUGH THE DEVICE. THERE WAS NO HARM OR INJURY TO THE PATIENT OR OPERATOR. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488810 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 62635756

    Patients

    Seq Age Sex Outcome Treatment
    1