BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVE TWIST STRAIGHT DRIVER

    MDR report key: 1062183 · Received June 13, 2008

    Report

    Report Number
    2249697-2008-00169
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. PREVIOUS EVENTS HAVE BEEN REVIEWED WITH THE SUSTAINING ENGINEERING TEAM. TASK ID WAS ISSUED IN 2007 TO INITIATE ECN. ECN WILL PUT NOTE ON THE INSTRUMENT "NOT TO TORQUE SCREWS" AND WILL UPDATE THE SURGICAL PROTOCOL REGARDING USE OF THE CAPTIVE TWIST STRAIGHT DRIVER. NO FURTHER ACTION IS REQUIRED AT THIS TIME. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR THE TRENDS. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON, REPORTED TO THE SALES REP THAT THE SCREW DRIVER (CAPTIVE TWIST DRIVER SHAFT) BROKE WHILE PUTTING THE SCREW INTO THE TRIDENT CUP. HE FURTHER REPORTED THAT A LITTLE PEACE OF THE SCREW DRIVER HAS REMAINED IN THE DOME HOLE PLUG IN THE TRIDENT CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIVE TWIST STRAIGHT DRIVER INSTRUMENT HXX STRYKER ORTHOPAEDICS MAHWAH NA SZH04

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other