BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1872513 · Received October 8, 2010

    Report

    Report Number
    9610667-2010-00008
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 8, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE IMPLANTATION OF A SHOULDER PROTHESIS THAT A DISTAL SEGMENT 3.5MM HEX TIP SCREW DRIVER TIP BROKE OFF WHILE TIGHTENING THE SCREW OF THE GLENOSPHERE COMPONENT. THE TIP SEGMENT COULD NOT BE EXTRACTED FROM THE SCREW HEAD SOCKET. THIS IS A KNOWN POTENTIAL ISSUE OF FAILURE WHERE EXCESSIVE TORQUE HAS BEEN APPLIED IN TOOL USE. THE SCREWDRIVER IS A CLASS 1 SURGICAL TOOL. DEVICE LOT NUMBER IS NOT REPORTED BUT MAY BE IDENTIFIED DURING TOOL EXAMINATION. THIS REPORT IS PROVIDED TO IDENTIFY AN EVENT OF INADVERTENT RESIDUAL FOREIGN BODY LEFT INDWELLING AT THE SURGICAL SITE WITHIN THE IMPLANT DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER SCREW DRIVER, 3.5MM, HEX TIP HXX TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other