BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASIF LOCKING SMALL FRAGMENT SET

    MDR report key: 2223221 · Received August 12, 2011

    Report

    Report Number
    2223221
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    February 9, 2009
    Report Date
    March 6, 2009
    Manufacturer
    ASIF
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DRILL BIT BROKE WHILE IN USE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASIF LOCKING SMALL FRAGMENT SET DRILL BIT HTW ASIF * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR