BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER TORQUE WRENCH

    MDR report key: 1960349 · Received December 16, 2010

    Report

    Report Number
    1526439-2010-00188
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY SPINE INC.
    Product Code
    HAO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRIVER WAS NOT RETURNED. THE TORQUE WRENCH WAS RETURNED AND TESTED. IT WAS FOUND THAT THE INNER MECHANISM WAS FROZEN AND NOT LIMITING TORQUE. WRENCH IS SUPPOSED TO CLICK OUT AT 80 IN/LBS. THE WRENCH WAS MANUFACTURED IN (B)(4) 2008 AND APPEARS TO HAVE SEEN MUCH USE. BREAKAGE OF THE TIP WAS CAUSED BY THE APPLICATION OF A TYPICAL FORCE BY THE USER DURING TIGHTENING. THE TORQUE WRENCH WAS NOT FUNCTIONING AS INTENDED AND DID NOT LIMIT TORQUE. DEVICE 2 OF 2. SEE ALSO: 1526439-2010-00187.

    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. THE DRIVER TIP SHEARED OFF INSIDE THE SETSCREW HEX DURING TIGHTENING. THE TIP 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 2 OF 2. SEE ALSO: 1526439-2010-00187.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER TORQUE WRENCH MANUAL SURGICAL INSTRUMENT HAO DEPUY SPINE INC. NA GB0908

    Patients

    Seq Age Sex Outcome Treatment
    1