BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROTEK CANNULATED SCREWDRIVER

    MDR report key: 411460 · Received August 15, 2002

    Report

    Report Number
    MW1025881
    Event Type
    Malfunction
    Date Received
    August 15, 2002
    Date of Event
    August 13, 2002
    Report Date
    August 15, 2002
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR WAS SCREWING IN A CANNULATED SCREW WHILE PERFORMING AN ARTHROSCOPIC LEFT ACL REPAIR, WHEN THE TIP OF THE SCREWDRIVER BROKE OFF INSIDE THE PT. THE BROKEN OFF TIP WAS JAMMED IN THE IMPLANTED SCREW. DR REMOVED THE TIP WITH A GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK CANNULATED SCREWDRIVER CANNULATED SCREWDRIVER HXX ARTHROTEK, INC. 900050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR