BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY SPINE SFX TORQUE DRIVE

    MDR report key: 1336933 · Received February 24, 2009

    Report

    Report Number
    1526439-2009-00029
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    February 2, 2009
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1526439-02/11/09-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFG ERROR FOR THIS PRODUCTION LOT (1208NT) RESULTED IN THE TIP COMPONENT BEING HEAT TREATED TO THE WRONG SPEC. AS A RESULT, THE TIP MAY STRIP OR FRACTURE BELOW THE 65 IN/LBS OF FORCE APPLIED TO LOCK THE SFX IMPLANT TO THE SPINAL ROD. IT IS UNLIKELY THAT BREAKAGE WOULD RESULT IN ANY ADVERSE PT OUTCOME. HOWEVER, THIS COULD RESULT IN A PORTION OF THE TIP BEING LEFT INSIDE THE IMPLANT OR A DELAY TO THE CASE TO REMOVE AND REPLACE THE IMPLANT. DEPUY SPINE HAS NOTIFIED OUR LOCAL OFFICE AND HAS UNDERTAKEN REMEDIAL ACTION TO REMOVE THIS LOT OF PRODUCT FROM THE FIELD.

    Description of Event or Problem · 1

    TWO SFX X-20 DRIVER TIPS BROKE OFF DURING TIGHTENING OF THE CROSSCONNECTOR. THE CROSSCONNECTORS WERE REMOVED AND OTHERS PLACED. A DRIVER FROM ANOTHER SET ON HAND WAS USED TO COMPLETE THE CASE. THE EVENT DID NOT RESULT IN ANY ADVERSE PT CONSEQUENCE. AS OUR INVESTIGATION DETERMINED THAT THE PRODUCT IN QUESTION WAS DISCREPANT, REMEDIAL ACTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE SFX TORQUE DRIVE MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE, INC. NA 1208NT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR