BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8722350 · Received June 21, 2019

    Report

    Report Number
    0001526350-2019-00501
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 13, 2019
    Report Date
    October 3, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). D4: UDI #: (B)(4). THE DEVICE HISTORY RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER 112770 WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH THE DEVICE. THE RECORD REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. USING THE MACHINE-REPAIR REPORTS AND THE REPAIR SITES FOLDERS TO QUERY FOR ALL REPAIRS ON SERIAL NUMBER (B)(6) PRIOR TO (B)(6) 2019, THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED. ON (B)(6) 2019, IT WAS REPORTED THAT THE POWER ON A DERMATOME WAS NOT STRONG. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME SERIAL NUMBER (B)(6) FOR EVALUATION. EVALUATION OF THE DEVICE ON 19 JULY 2019 NOTED THAT THE CALIBRATION WAS SLIGHTLY OUT OF SPECIFICATIONS ONLY AT THE ZERO SETTING, BUT THE DEVICE WAS RUNNING WITHIN MOTOR SPEED SPECIFICATIONS. REPAIR OF THE DERMATOME OCCURRED ON 19 JULY 2019 AND INVOLVED REPLACING THE VESPEL AND SEMI-CIRCLE BEARINGS AND RECALIBRATING THE DEVICE. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DERMATOME WAS FUNCTIONING AS INTENDED, THEN RETURNED THE DEVICE TO THE CUSTOMER WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE SERVICE TECHNICIAN WAS UNABLE TO REPRODUCE THE REPORTED LOSS OF STRENGTH ISSUES WITH THE DERMATOME. IN ADDITION, THE HOSE USED WITH THE DEVICE WAS NOT PROVIDED FOR EVALUATION. AS SUCH, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT 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. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THAT THERE ARE NO FURTHER ACTIONS NEEDED AT THIS TIME. 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 AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT'S POWER WAS NOT STRONG. THIS IS CREATED TO CAPTURE THE UNKNOWN NUMBER OF TIMES THAT THIS MALFUNCTION HAS OCCURRED IN THE PAST SINCE IT WAS INDICATED THAT IT HAS HAPPENED MORE THAN ONCE BEFORE. THIS TOOK PLACE DURING SURGERY BUT THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516322 ZIMMER AIR DERMATOME DERMATOME, PNEUMATICALLY-POWERED GFD ZIMMER SURGICAL, INC. 63415160

    Patients

    Seq Age Sex Outcome Treatment
    1