BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 1933329 · Received December 14, 2010

    Report

    Report Number
    2249697-2010-01738
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: VISUAL INSPECTION INDICATED THAT THE DEVICE WAS RETURNED IN USED CONDITION. THE TIP OF THE UNIVERSAL DRIVER SHAFT SHEARED OFF. THIS EVENT IS RELATED TO SIMILAR EVENTS WHERE THE TIP ON THE UNIVERSAL AND STRAIGHT DRIVER SHAFT TWISTS AND/OR FRACTURES. SIMILAR PREVIOUS EVENTS INDICATED THAT THE TIP OF THIS DRIVER DEFORMED DUE TO TORSIONAL OVERLOAD. THIS FAILURE MODE IS OBSERVED WHEN THE DRIVER IS OVER TORQUED, THE DRIVER TIP 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: "SCREWDRIVER BROKE WHILE SCREWING SCREW INTO ACETABULUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F3S6223

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention