BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 5073883 · Received September 14, 2015

    Report

    Report Number
    5073883
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    July 20, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORIF LEFT FEMUR PROCEDURE WAS BEING PERFORMED BY MD WHEN ORTHO DRILL BIT TIP BROKE OFF INSIDE BONE. MD LEFT BROKEN PART IN DRILL HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606478 DRILL BIT HTW SYNTHES (USA) PRODUCTS LLC 324.213

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES