BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE DRIVER

    MDR report key: 2061970 · Received March 18, 2011

    Report

    Report Number
    2249697-2011-00348
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    AS
    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, "DURING REAMING OF THE FEMORAL CANAL, THE TRIATHLON T HANDLE BROKE AND SEPARATED FROM THE REAMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-HANDLE DRIVER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA N2A07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other