BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER X-25 FINAL TIGHTENER

    MDR report key: 1960356 · Received December 16, 2010

    Report

    Report Number
    1526439-2010-00181
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 19, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE DRIVERS UNDER MAGNIFICATION SHOWED PLASTIC DEFORMATION, AS THE TIP SHEARED OFF IN TORSION. THE TORQUE WRENCH WAS TESTED AND IT WAS FOUND THAT THE INNER MECHANISM WAS FROZEN AND NOT LIMITING TORQUE. (B)(4). THE WRENCH WAS MANUFACTURED IN 09/2008, AND APPEARS TO HAVE SEEN MUCH USE. BREAKAGE OF THE TIP WAS CAUSED BY THE APPLICATION OF ATYPICAL FORCE BY THE USER DURING TIGHTENING. THE TORQUE WRENCH WAS NOT FUNCTIONING AS INTENDED AND DID NOT LIMIT TORQUE.

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO TIGHTEN THE SETSCREW DOWN IN A SPINAL CONSTRUCT BUT REPORTED THAT THE TORQUE HANDLE DID NOT CLICK OUT. TWO DRIVER TIPS WERE SHEARED OFF INSIDE THE SETSCREW HEX DURING TIGHTENING. THE TIPS WERE COLD WELD IN THE SETSCREW AND CANNOT MIGRATE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE AS A RESULT OF THIS EVENT. AS AN UNINTENDED PORTION OF THE DEVICE WAS LEFT IN VIVO, AN MDR IS FILED TO DOCUMENT THIS MALFUNCTION. DEVICE 1 OF 3. SEE ALSO: 1526439-2010-00182 AND 1526439-2010-00183.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER X-25 FINAL TIGHTENER MANUAL SURGICAL DEVICE LXH DEPUY SPINE INC. NA X01208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK