BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1882900 MINI TREPHINATION 2MM

    MDR report key: 2918087 · Received January 16, 2013

    Report

    Report Number
    1045254-2013-00038
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: (B)(6) 2013. THE DEVICE WAS RETURNED AND EVALUATED BY THE QUALITY ENGINEERING TEAM. THE SAMPLE WAS RETURNED WITHOUT THE ORIGINAL POUCH AND PRODUCT LABEL. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THE PRODUCT APPEARED TO BE A DRILL MINI TREPHINATION DEVICE. FROM THE CONDITION OF THE RETURNED DEVICE, CUSTOMER USE WAS VISIBLE. FROM VISUAL EVALUATION, THE SHAFT WAS FOUND BROKEN CLOSE TO PROXIMAL END. THE BROKEN PIECE MEASURED APPROXIMATELY 1.5CM. THE DRILL BIT REMAINED INTACT ON THE BROKEN PROXIMAL PIECE OF THE SHAFT AND APPEARED FREE OF DAMAGE. THERE WAS OBVIOUS DISCOLORATION AND MARKINGS ON THE SHAFT WHICH WERE VISIBLE VIA THE NAKED EYE AND INDICATED SEVERE CUSTOMER HANDLING / USE OF THE DEVICE. THE REPORTED COMPLAINT WAS CONFIRMED WITH THE MOST LIKELY ROOT CAUSE OF SEVERE HANDLING AND USE.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRILL BIT BROKE OFF THE DEVICE AND FLEW ACROSS THE ROOM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23306 DRILL 1882900 MINI TREPHINATION 2MM BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1882900 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1