BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONEMULCH/WASHERLOC DISP. KIT

    MDR report key: 390837 · Received April 18, 2002

    Report

    Report Number
    2027970-2002-00001
    Event Type
    Injury
    Date Received
    April 18, 2002
    Date of Event
    March 8, 2002
    Report Date
    April 18, 2002
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    HTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY IN 2002, TIP OF K-WIRE BROKE OFF IN FEMUR. AFTER CONFIRMATION OF TIP IN FEMUR BY FLOROSCAN, SURGEON ELECTED NOT TO REMOVE FRACTURED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONEMULCH/WASHERLOC DISP. KIT INSTRUMENT, KIT HTZ ARTHROTEK, INC. NA 643020

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other