BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 1951178 · Received December 13, 2010

    Report

    Report Number
    2249697-2010-01715
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: VISUAL INSPECTION INDICATED THAT THE DEVICE WAS RETURNED IN USED CONDITION. THE TIP OF THE UNIVERSAL DRIVER SHAFT IS TWISTED AND DEFORMED. THIS EVENT IS RELATED TO SIMILAR EVENTS WHERE THE TIP ON THE UNIVERSAL AND STRAIGHT DRIVER SHAFT TWISTS AND/OR FRACTURES. SIMILAR PREVIOUS PERS INDICATED THAT THE TIP OF THE DRIVER DEFORMED DUE TO TORSIONAL OVERLOAD. THE DRIVER TI WEARS EXCESSIVELY DUE TO REPEATED USE OF THE DRIVER, OR WHEN THE DRIVER TIP IS ANGULATED EXTREMELY WITHIN THE SCREW HEAD DURING USE. THE ROOT CAUSE OF THIS EVENT IS LIKELY USER RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PUTTING IN A SCREW IN THE TRIDENT CUP AND THE TIP OF THE SCREWDRIVER TWISTED AND DEFORMED. IT WAS UNUSABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F5A9383

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention