BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER 2 TORQUE DRIVER SHAFT

    MDR report key: 1881725 · Received October 11, 2010

    Report

    Report Number
    1526439-2010-00145
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE DRIVER (DEVICE 1) FOUND NO MANUFACTURING OR MATERIAL DEFECTS. TESTING OF THE TORQUE LIMITING HANDLE (DEVICE 2) CONFIRMED THAT IT WAS WORN FROM USE OVER TIME AND WAS NOT LIMITING TORQUE. THIS APPEARS TO HAVE RESULTED IN THE APPLICATION OF ATYPICAL FORCE ON THE DRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW DRIVER TIP BROKE OFF DURING SCREW INSERTION. TIP COULD NOT BE EASILY REMOVED AND WAS LEFT IN THE HEX AND THE SPINAL ROD PLACED OVER IT. THERE WAS NO ADVERSE IMPACT TO THE PT OR PROCEDURE AS A RESULT OF THIS MALFUNCTION. AS AN UNINTENDED PORTION OF THE DEVICE WAS LEFT IN THE IMPLANT, AN MDR IS FILED TO DOCUMENT THE EVENT. THE BROKEN FRAGMENT WAS STUCK IN THE IMPLANT HEX AND THE ROD PLACED OVER IT, AS SUCH THERE IS NO FEAR OF MIGRATION. DEVICE 1, SEE ALSO: 1526439-2010-00146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER 2 TORQUE DRIVER SHAFT MANUAL SURGICAL INSTRUMENT HXX DEPUY SPINE, INC. NA X0610

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR