BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1882900 MINI TREPHINATION 2MM

    MDR report key: 3506860 · Received December 9, 2013

    Report

    Report Number
    1045254-2013-00594
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    November 14, 2013
    Report Date
    November 14, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO MEDTRONIC'S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION PURPOSES. ANALYSIS RESULTS ARE DETAILED AS FOLLOWS: THE CONDITION OF THE DEVICE SHOWED POSSIBLE CUSTOMER USE / HANDLING. UPON VISUAL EVALUATION, THE TIP OF INNER DRILL ASSEMBLY WAS FOUND BROKEN AND THE BROKEN PIECE MEASURED APPROXIMATELY 1.5CM. NO DAMAGE WAS NOTICED ON THE TREPHINE DRILL HUB COMPONENT NOR THE HUB OF THE INNER DRILL ASSEMBLY. AS PER THE EVENT DESCRIPTION, IT IS INDICATED THAT THE BUR BROKE DURING TESTING BUT THE HANDPIECE WAS NOT LOCKED AND THE FOOT PEDAL WAS PRESSED. THE BUR SHOULD BE PLACED IN LOCK POSITION INSIDE THE HANDPIECE BEFORE HANDLING/USE. BASED ON EVALUATION AND OBSERVATION OF THE DEVICE, THE COMPLAINT WAS CONFIRMED FOR THE REPORTED MALFUNCTION (BROKEN TIP). THE EVENT OCCURRED PRIOR TO USE AND IS MOST LIKELY RELATED TO CUSTOMER MISHANDLING OF THE PRODUCT. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR TIP OF THE 2MM MINI-TREPHINATION DRILL BROKE OFF WHILE TESTING IT INTRAOPERATIVELY, PRIOR TO USE ON THE PATIENT. RIGHT AT THE MOMENT THE FOOT PEDAL WAS DEPRESSED IN FORWARD MODE AT 12000RPM, THE TIP BROKE OFF AS SOON AS IT WAS ACTIVATED BY THE MICRODEBRIDER. THE MICRODEBRIDER WAS NOT IN LOCK POSITION AT THE TIME AND THE BROKEN TIP WAS RECOVERED SUCCESSFULLY WITHOUT ANY ADDITIONAL PROCEDURES OR EQUIPMENT, AS THE BROKEN TIP FRAGMENT FELL ON THE FLOOR AND NOT INTO THE SURGICAL FIELD. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640440 DRILL 1882900 MINI TREPHINATION 2MM BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1882900 NI

    Patients

    Seq Age Sex Outcome Treatment
    1