BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX X-20 TORQUE DRIVER

    MDR report key: 1613590 · Received February 17, 2010

    Report

    Report Number
    1526439-2010-00032
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 18, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS WERE RETURNED AND PROBLEM CONFIRMED. TORQUE WRENCH RETURNED (DEVICE 2) WAS FUNCTIONALLY TESTED AND CONFIRMED TO BE OUT OF SPECIFICATION AT THIS TIME. THE WRENCH WHICH WAS MANUFACTURED IN 9/2006 TO 65 IN/LBS IS PROVIDING AN AVG. OF 91.7 IN/LBS OF TORQUE AT THIS TIME. THIS INDICATES THAT THE BREAKAGE OF THE DRIVER TIP (DEVICE 1) WAS RELATED TO THE OUT OF TOLERANCE CONDITION OF THE TORQUE WRENCH. BASED ON THE AGE OF THE DEVICE THIS PROBLEM CAN BE ATTRIBUTED TO WEAR OVER TIME.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT WHILE FINAL TIGHTENING THE CROSS CONNECTOR, THE TIP OF X20 DRIVER SHAFT SHEARED OFF. SURGEON HAD TO REMOVE RODS AND REPLACE THE HARDWARE. CONTACT REPORTED THAT THE PROBLEM RESULTED IN A DELAY TO THE CASE IN EXCESS OF 30-MIN, HOWEVER, THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. AS THE CASE WAS SIGNIFICANTLY DELAYED AN MDR IS FILED TO DOCUMENT THIS EVENT. DEVICE 1. SEE ALSO: 1526439-2010-00033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SFX X-20 TORQUE DRIVER MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE, INC. NA 0709NT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR