BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRADRIVE III

    MDR report key: 1285385 · Received January 13, 2009

    Report

    Report Number
    2950285-2009-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    December 9, 2008
    Report Date
    January 7, 2009
    Manufacturer
    BIOMET SPORTS MEDICINE REDDING
    Product Code
    JDX
    PMA / PMN Number
    K900003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS AND TESTING OF THE HANDPIECE DETERMINED THE HANDPIECE CABLE FAILED DUE TO AGE AND WEAR. THE DEVICE HISTORY RECORD WAS REVIEWED, AND SHOWED THE PRODUCT WAS RELEASED WITHOUT ANOMALIES OR DEVIATIONS.

    Description of Event or Problem · 1

    AN ULTRADRIVE HANDPIECE MALFUNCTIONED DURING A ROUTINE SURGERY. DURING OPERATION OF THE HANDPIECE THE PHYSICIAN ASSISTANT NOTED A BROWN SPOT ON THE HANDPIECE CABLE THAT BEGAN EMITTING SMOKE, AND THEN A SMALL FLAME. THE HANDPIECE WAS UNPLUGGED AND THE SURGERY WAS CONTINUED WITH A BACKUP HANDPIECE. THERE WAS NO DELAY IN THE SURGERY, AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRADRIVE III ULTRADRIVE HAND PIECE JDX BIOMET SPORTS MEDICINE REDDING ULTRADRIVE 409130

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other