BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVE TWIST STRAIGHT DRIVER

    MDR report key: 1082424 · Received July 21, 2008

    Report

    Report Number
    2249697-2008-00208
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULT OF THE INVESTIGATION INDICATES THAT THE CAPTIVE TWIST STRAIGHT DRIVER WAS USED TO TIGHTEN THE SCREW. AS A RESULT, THE DRIVER TIP WAS TORSIONALLY LOADED CAUSING DRIVER TIP TO FRACTURE IN TORSIONAL SHEAR. IT SHOULD BE NOTED THAT THE CAPTIVE TWIST DRIVER IS ONLY INTENDED TO INITIATE A SCREW OR PLUG INTO THE SHELL. ONLY A STANDARD T-20 DRIVER, CAT 2107-101X, SHOULD BE USED TO TORQUE A SCREW OR PLUG INTO THE SHELL. IF ADDITIONAL INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE CAPTIVE TWIST TIP BROKE OFF IN THE SCREWHEAD OF THE CAPSCREW IN THE TRIDENT SHELL. TIP COULD NOT BE REMOVED, LEFT IN PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIVE TWIST STRAIGHT DRIVER INSTRUMENT HXX STRYKER ORTHOPAEDICS MAHWAH NA S2C06

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other