BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICONIX 1.4MM DISPOSABLE DRILL

    MDR report key: 3192300 · Received June 13, 2013

    Report

    Report Number
    3192300
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISTAL PORTION OF DRILL BIT BROKE OFF IN PATIENT. COULD NOT BE REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RT ORIF INTERNAL FIXATION OF CALCANEOUS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269711 ICONIX 1.4MM DISPOSABLE DRILL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MBI STRYKER ENDOSCOPY * 13016AG2

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR