BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2150557 · Received June 22, 2011

    Report

    Report Number
    9610667-2011-00015
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF FAILED DEVICE HAS NOT BEEN PROVIDED. NO ADDITIONAL INFO IS ANTICIPATED FOR THIS EVENT. THIS IS THE FINAL REPORT THAT WILL BE FILED ASSOCIATED WITH THIS EVENT AND DEVICE. THIS IS A KNOWN POTENTIAL ISSUE OF FAILURE WHERE EXCESSIVE TORQUE HAS BEEN APPLIED IN TOOL USE.

    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. THE SCREWDRIVER IS A CLASS 1 SURGICAL TOOL. 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