BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2121326 · Received June 6, 2011

    Report

    Report Number
    2520274-2011-00181
    Event Type
    Injury
    Date Received
    June 6, 2011
    Report Date
    May 11, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED AT THIS TIME. UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER, AND/OR DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    PT STATUS POST NAIL AND BLADE IMPLANTATION RETURNED TO SURGEON FOR POST OP VISIT. AN X-RAY SHOWED THE HELICAL BLADE HAD PENETRATED THE HIP JOINT. SURGEON NOTED HE HAD DIFFICULTY PLACING THE BLADE AND WAS UNABLE TO INSERT THE DISTAL LOCKING SCREW AT IMPLANTATION PROCEDURE. SURGEON IS MONITORING THE PT AND THE HARDWARE HAS NOT BEEN REMOVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI HELICAL BLADE KTT SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention NAIL| INSERTION HANDLE