BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED II DISPOSABLE DRIVER TIP

    MDR report key: 3111738 · Received May 7, 2013

    Report

    Report Number
    9610667-2013-00088
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    TORNIER SAS
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    TIP OF HEX DRIVER BROKE OFF AND STUCK IN GLENOSPHERE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199930 AEQUALIS REVERSED II DISPOSABLE DRIVER TIP NONE HSD TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR