BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8277193 · Received January 25, 2019

    Report

    Report Number
    0001526350-2019-00051
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    December 24, 2018
    Report Date
    March 26, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. THE DEVICE HISTORY RECORD AND PREVIOUS REPAIR RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) WAS REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE RECORD REVIEWS FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO FOUND THE WORN COMPONENTS DURING EVALUATION OF THE DEVICE. ON 18 JANUARY 2019, IT WAS REPORTED FROM ROYAL NTH SHORE HOSPITAL PUB NSW THAT A DERMATOME HAD TORN SKIN AND CAUSED A HEMATOMA. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME, SERIAL NUMBER (B)(4), TO ZIMMER AUSTRALIA FOR EVALUATION. EVALUATION OF THE DEVICE BY ZIMMER AUSTRALIA ON 18 JANUARY 2019 FOUND THAT THE MACHINED HEAD AND RETURNED WIDTH PLATES WERE WORN AND THAT THE COMPONENTS NEEDED TO BE REPLACED. THE DEVICE WAS TO BE FORWARDED TO ZIMMER TAIWAN FOR FURTHER EVALUATION, BUT THE CUSTOMER DECLINED THE QUOTE FOR SERVICE. AS SUCH, THE DEVICE WAS RETURNED TO THE CUSTOMER WITHOUT FURTHER EVALUATION OR SERVICE PERFORMED. REFERENCE NUMBER (B)(4) ON 18 JANUARY 2019. WHILE THE SERVICE TECHNICIAN FOUND THAT THE DEVICE HAD A WORN MACHINE HEAD AND THAT THE DEVICE WAS PROVIDED WITH WORN WIDTH PLATES, WHICH CAN CAUSE THE DERMATOME TO NOT CUT AS INTENDED, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED HOW THESE COMPONENTS CONTRIBUTED TO THE TEARING SKIN OR HEMATOMA EVENTS. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE TEARING SKIN AND HEMATOMA EVENTS CANNOT BE DETERMINED. 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 RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SKIN WAS TORN AND CAUSED A HEMATOMA. EVENT OCCURRED DURING SURGERY AND AN ALTERNATIVE DEVICE WAS USED. THERE WAS NO DELAY REPORTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71524 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 60032027

    Patients

    Seq Age Sex Outcome Treatment
    1