BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM ILIAC SCREWDRIVER

    MDR report key: 7342444 · Received March 15, 2018

    Report

    Report Number
    0009617544-2018-00066
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 8, 2018
    Report Date
    May 25, 2018
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    UDI-DI
    07613327265279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. RESULT: THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA VISUAL INSPECTION. 2 OUTER SLEEVES WERE RETURNED FOR LOT 141256. NO ISSUE WAS FOUND WITH ONE OUTER SLEEVE. THE OTHER OUTER SLEEVE HAD FRACTURED THREADING. THE FRACTURED PIECE WAS NOT RETURNED. THE INNER SHAFT RETURNED HAD A FRACTURED TIP AND THE THREADING WAS DEFORMED. MANUFACTURING HISTORY WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. CONCLUSION: ACCORDING TO SIMILAR MATERIAL ANALYSIS AND THE EVENT DESCRIPTION, THE MOST LIKELY ROOT CAUSE IS EXCESSIVE FORCE WAS APPLIED TO THE DRIVER CAUSING IT TO FRACTURE AND DEFORM. IT IS POSSIBLE IMPROPER SCREW HOLE PREPARATION, HARD BONE QUALITY, UNDER TAPPING, OR MISALIGNMENT OF THE DRIVER TO THE SCREW CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TOO MUCH TORQUE WAS APPLIED TO CLOSED HEAD ILIAC SCREWDRIVERS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOO MUCH TORQUE WAS APPLIED TO CLOSED HEAD ILIAC SCREWDRIVERS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183485 XIA 3 TITANIUM ILIAC SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-US 48231326 141256 07613327265279

    Patients

    Seq Age Sex Outcome Treatment
    1