BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA SURGICAL BUR

    MDR report key: 5873643 · Received August 12, 2016

    Report

    Report Number
    2025102-2016-00006
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    July 7, 2014
    Report Date
    August 12, 2016
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITH THE INFORMATION PROVIDED AND WITHOUT THE HANDPIECE OR BUR USED DURING THE PROCEDURE FOR EVALUATION WE CANNOT DETERMINE THE CAUSE. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE FAILURE MAY BE RELATED TO A HANDPIECE THAT IS NOT FUNCTIONING PROPERLY MOST LIKELY RELATED TO A LACK OF MAINTENANCE. EXCESSIVE VIBRATIONS COULD CAUSE THE BUR TO UNLOCK FROM POSITION DURING USE. A REVIEW OF THE DHR FOR THE RELATED BUR INDICATED THE PRODUCT WAS WITHIN SPECIFICATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    RECEIVED USER FACILITY MDR REPORT FROM FDA: DURING THE TOTAL KNEE REVISION ON (B)(6) 2014, A BUR WAS ATTACHED TO THE MICRO 100 POWER SYSTEM DEVICE AND REPORTEDLY LOCKED INTO PLACE. THE SURGEON FEELS THE VIBRATION OF THE DRILL CAUSED THE BUR TO LOOSEN FROM POSITION AND FALL INTO THE PATIENT'S TIBIAL CANAL. THEY WERE UNABLE TO RETRIEVE THE BUR FROM INSIDE THE BONE, THERE REMAINS A RETAINED BUR TIP IN THE PATIENT'S DISTAL TIBIAL CANAL. ORIGINAL PROCEDURE : LEFT DISTAL FEMORAL REPLACING LEFT TOTAL KNEE ARTHROPLASTY; REMOVAL OF LEFT FEMORAL NAIL. DEVICE USED: HALL MICRO 100 DRILL, SERIAL # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523537 BRASSELER USA SURGICAL BUR SURGICAL BUR GFF BRASSELER U.S.A. MEDICAL, LLC 09-C0901 4.0 X 8.0MM OVAL 70.0MM NH9DD

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR