BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 1991486 · Received January 28, 2011

    Report

    Report Number
    2249697-2011-00103
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    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

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "TIP OF THE SCREWDRIVER BROKE OFF IN THE ACETABULAR SCREW. THE TIP WAS STUCK IN THE SCREW AND SO WAS LEFT IN THE PATIENT. WAS FLUSH WITH THE TOP OF THE SCREW, SO DID NOT OBSTRUCT THE INSERTION OF THE LINER."

    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 47 YR Other