BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED

    MDR report key: 2033184 · Received March 9, 2011

    Report

    Report Number
    2033184
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 9, 2011
    Manufacturer
    TORNIER
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS ATTEMPTING TO TIGHTEN A SCREW INTO AN IMPLANT WHEN THE HEAD OF THE SCREW DRIVER BIT BROKE OFF IN THE SCREWHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEQUALIS REVERSED HEX SCREW DRIVER BIT HTW TORNIER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR