BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR AIR DERMATOME HANDPIECE

    MDR report key: 9401049 · Received December 3, 2019

    Report

    Report Number
    0001526350-2019-01093
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Report Date
    January 29, 2020
    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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE DEVICE HISTORY RECORD AND PREVIOUS REPAIR RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER 110131 WAS REVIEWED AND NOTED NO RELATED NONCONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH THE DEVICE. THE RECORD REVIEWS FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 13 NOVEMBER 2019, IT WAS REPORTED THAT A DERMATOME WAS JUDDERING WHILE TAKING A GRAFT. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME SERIAL NUMBER 110131 FOR EVALUATION. EVALUATION OF THE DEVICE ON 22 NOVEMBER 2019 NOTED THAT THE NEEDLE BEARING WAS DEFECTIVE WAS OUT OF CALIBRATION AT THE TWENTY SETTING AND THAT THE CONTROL BAR WAS NOT IN THE CORRECT POSITION ON THE DEVICE. THE DERMATOME WAS NOTED TO BE RUNNING WITHIN MOTOR SPEED SPECIFICATIONS. REPAIR OF THE DERMATOME OCCURRED ON 29 NOVEMBER 2019 AND INVOLVED REPLACING THE NEEDLE BEARING AS WELL AS RECALIBRATING THE DEVICE AND REPOSITIONING THE CONTROL BAR. 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. WHILE THE CUSTOMER DOES ADMIT THAT THE DEVICE HAD NOT BEEN SERVICED WITHIN THE RECOMMENDED YEARLY TIMEFRAME, THE SERVICE TECHNICIAN WAS UNABLE TO REPRODUCE THE REPORTED EVENT OR FIND A FAILURE THAT WOULD RESULT IN THE EVENT OCCURRING DURING EVALUATION OF THE DEVICE. AS SUCH, A SPECIFIC CAUSE OF THE REPORTED JUDDERING ISSUE 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

    IT WAS REPORTED THAT THE CUSTOMER SAID THAT THE DERMATOME JUDDERED WHILE TAKING A GRAFT. THERE WAS NO ISSUE WITH ANY PATIENT AND THEY ACKNOWLEDGED THAT THE ISSUE WAS ENTIRELY DUE TO THE FACT IT WAS OVERDUE THE SERVICE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). REPORT SOURCE - FOREIGN - (B)(6). (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER SAID THAT THE DERMATOME JUDDERED WHILE TAKING A GRAFT NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199222 ZMR AIR DERMATOME HANDPIECE DERMATOME GFD ZIMMER SURGICAL, INC. 61338529

    Patients

    Seq Age Sex Outcome Treatment
    1