BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT TORQUE LIMITING DRIVER

    MDR report key: 1060017 · Received June 11, 2008

    Report

    Report Number
    1526439-2008-00114
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    February 25, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TORQUE LIMITING DRIVER WAS TESTED FOR TORQUE, AND THE RESULTS WERE FOUND TO BE ABOVE THE MAXIMUM SPECIFICATION REQUIREMENT. SUBSEQUENT LAB TESTING DETERMINED THAT IT IS POSSIBLE THAT THE INSTRUMENT'S ABOVE SPECIFICATION CONDITION MAY HAVE CAUSED OR CONTRIBUTED TO THE TIP BREAKAGE OF THE SUMMIT HEX DRIVER SHAFT REPORTED MFG MEDWATCH REPORT NO. 1526439-2008-00068. THE CAUSE OF THE ABOVE SPECIFICATION TORQUE CONDITION CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE INSTRUMENT WAS MANUFACTURED IN MAY 2001 AND HAS BEEN IN SERVICE FOR APPROXIMATELY SEVEN YEARS. IT IS LIKELY THAT THE INSTRUMENT BECAME WORN THROUGH NORMAL, ROUTINE USAGE OVER TIME.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTED THAT THE TORQUE LIMITING DRIVER PROVIDED EXCESSIVE TORQUE DURING SCREW TIGHTENING. SEE MEDWATCH REPORT NO. 1526439-2008-00068 FOR A SUMMIT HEX DRIVER SHAFT WITH A BROKEN TIP THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT TORQUE LIMITING DRIVER ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE, INC. NA E0501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SUMMIT CROSS CONNECTOR ASSEMBLY:| 274669100| SUMMIT 2.0MM HEX DRIVER SHAFT:| 17466500