BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED 3.5MM HEXAGONAL TIP DRIVER

    MDR report key: 2922071 · Received January 15, 2013

    Report

    Report Number
    9610667-2013-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    TORNIER INC
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    WHEN SCREWING THE GLENOID THE SCREWDRIVER BROKE IN THE GLENOID, WE COULD NOT SCREW OR UNSCREW THE GLENOID, THE THREAD WAS NOT COMPLETELY SCREWED. IT WAS IMPOSSIBLE TO REMOVE WITHOUT TEARING THE GLENOID PLATE BEHIND. THE SURGEON HAD COMPLIED WITH THE OPERATIVE TECHNIQUE, IMPACTED THE GLENOID WITH THE IMPACTOR AND THE GLENOID SCREW WITH THE SCREWDRIVER. THERE HAS BEEN NO PRESSURE ON THE SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22954 AEQUALIS REVERSED 3.5MM HEXAGONAL TIP DRIVER DRIVER HXX TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention