BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5" FIXATOR PIN

    MDR report key: 556885 · Received May 4, 2004

    Report

    Report Number
    1723170-2004-00004
    Event Type
    Malfunction
    Date Received
    May 4, 2004
    Date of Event
    April 9, 2004
    Report Date
    May 4, 2004
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO (2) 5" FIX PINS BROKE IN PT'S FEMUR WHILE SURGEON WAS ATTEMPTING TO REMOVE PINS AFTER PROCEDURE. OR STAFF ADMITTED TO USING THESE SINGLE USE PINS MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5" FIXATOR PIN IGS INSTRUMENT LXH MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 9730477 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *