BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 FEMUR

    MDR report key: 2945753 · Received January 4, 2013

    Report

    Report Number
    9610622-2013-90004
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    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

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A TS FEMORAL NAIL SYSTEM UPON COMPLETION SURGEON NOTICED PIECE OF METAL INSIDE TOP OF NAIL. PART OF METAL TARGETING ARM THAT BROKE OFF. ABLE TO REMOVE METAL FROM NAIL WITH NO ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5844 NAIL HANDLE T2 FEMUR INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP203562

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other