BEUDAMED
    FDA Adverse Event Other Summary report: N

    5" FIX PIN

    MDR report key: 799788 · Received December 9, 2004

    Report

    Report Number
    1723170-2004-00007
    Event Type
    Other
    Date Received
    December 9, 2004
    Date of Event
    November 10, 2004
    Report Date
    November 24, 2004
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NEGATIVE PATIENT OUTCOMES HAVE BEEN REPORTED TO MSNT. EVALUATION- ALTHOUGH THE BROKEN PINS WERE DISCARDED AT THE SITE AND UNAVAILABLE FOR ANALYSIS, IT WAS COMMUNICATED TO MSNT THAT THE SITE DOES NOT TRACK THE NUMBER OF TIMES THESE DEVICES HAVE BEEN USED. THEREFORE, IT IS OUR CONCLUSION THAT THE FAILURE WAS RELATED TO REUSE OF A SINGLE-USE DEVICE.

    Description of Event or Problem · 1

    TWO (2) 5" FIXATOR BROKE DURING A KNEE PROCEDURE. THE BROKEN PORTIONS OF THE PINS WERE NOT REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5" FIX PIN ORTHOPAEDIC IMAGE-GUIDED SURGERY FIX PIN HAW MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 9730477 200312231601

    Patients

    Seq Age Sex Outcome Treatment
    1 *