BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1882900 MINI TREPHINATION 2MM

    MDR report key: 3066565 · Received April 18, 2013

    Report

    Report Number
    1045254-2013-00338
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED AND PRODUCT EVALUATION IS CURRENTLY UNDERWAY. THE PRELIMINARY ANALYSIS CONFIRMED THE DRILL BIT TIPS WERE DETACHED. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: UPON EVALUATION, THE SHAFTS ON BOTH OF THE RETURNED SAMPLES WERE BROKEN CLOSE TO THE DISTAL END. THE BROKEN PIECES MEASURED APPROXIMATELY 1.7CMS. ONE SAMPLE SHOWED CIRCULAR WEAR MARKS, POSSIBLY INDICATING EXCESSIVE USE/HANDLING OF THE DEVICE BY THE CUSTOMER AND LONG RUN TIME. THE SECOND SAMPLE DID NOT EXHIBIT ANY OBVIOUS MARKINGS ON THE SHAFT. THE BREAKAGE APPEARED TO HAVE OCCURRED AT THE SHARP CORNER / BREAK EDGE. THE OUTER DIAMETER OF THE SHAFT MEASURED APPROXIMATELY 0.0920" WHICH MEETS THE REQUIRED SPECIFICATION OF 0.092"+.0006-.0000. UNDER MAGNIFICATION, THE DRILL BIT TIPS DID NOT REVEAL ANY OBVIOUS DAMAGE OR FRAGMENTATION. THE CUSTOMER¿S COMPLAINT WAS CONFIRMED; THE EXACT ROOT CAUSE OF THE COMPLAINT WAS NOT CONFIRMED, THE MOST LIKELY / PROBABLE CAUSE OF THE ISSUE APPEARS TO BE RELATED WITH CUSTOMER MISUSE / MISHANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF TWO DRILL BITS BROKE OFF ONCE THE HANDPIECE WAS ACTIVATED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167970 DRILL 1882900 MINI TREPHINATION 2MM BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1882900 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1