BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 3155641 OTO-FLEX 1MM DIAMOND ORANGE/

    MDR report key: 2992466 · Received March 7, 2013

    Report

    Report Number
    1045254-2013-00225
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE QUALITY ENGINEER ANALYZED THE RETURNED DEVICE. UPON OBSERVATION, THE SHAFT WAS FOUND BROKEN CLOSE TO THE PROXIMAL END OF THE BUR (AT THE HANDPIECE ENGAGEMENT END). THIS IS THE END THAT IS SEATED INSIDE THE SKEETER ULTRA-LITE OTO-TOOL HANDPIECE AND LOCKED FOR CUSTOMER USE. THE BROKEN PIECE MEASURED APPROXIMATELY 0.5CM. THE BROKEN PIECE DID NOT SHOW ANY ANOMALIES WHEN COMPARED TO DRAWING (B)(4) - BLANK BUR, OTO FLEX. A PORTION OF BROKEN SHAFT REMAINED INTACT TO THE HANDPIECE ENGAGEMENT END. THE BUR TIP (HEAD) WAS FOUND INTACT AND UNBROKEN. UNDER MAGNIFICATION, THERE WAS DISCOLORATION, MARKINGS AND RESIDUE OBSERVED ON THE BUR HEAD AND THE SHAFT INDICATING EXCESSIVE CUSTOMER USE / HANDLING OF THE DEVICE. THE ORANGE AND WHITE TUBES ON THE SHAFT WERE FOUND UNDAMAGED. THE MOST LIKELY CAUSE FOR THIS IS MISUSE/ MISHANDLING. RESULTS - FATIGUE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE TYMPANOPLASTY THE BUR OF THE SKEETER DRILL BROKE OFF DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97141 BUR 3155641 OTO-FLEX 1MM DIAMOND ORANGE/ BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC 3155641 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1