BEUDAMED
    FDA Adverse Event Summary report: N

    LCP MODULAR MINI FRAGMENT SYSTEM

    MDR report key: 1841629 · Received September 13, 2010

    Report

    Report Number
    1841629
    Date Received
    September 13, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADULT PATIENT WITH FRACTURE OF LEFT ANKLE HAD ORIF PERFORMED AND DURING THE PROCEDURE, A SYNTHES K-WIRE(1.25 MM) WAS BROKEN. THE BROKEN PIECE OF WIRE COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT'S ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP MODULAR MINI FRAGMENT SYSTEM KIRSCHNER WIRE HRS SYNTHES * 5891010

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR