BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER

    MDR report key: 2940449 · Received February 4, 2013

    Report

    Report Number
    1719045-2013-00235
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE LOT NUMBER WAS REPORTED AS 6574061; THE LOT NUMBER (6574061) CANNOT BE CONFIRMED AS A SYNTHES LOT NUMBER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL CONSTRUCT ON AN UNKNOWN DATE. PATIENT WAS PRESENTED WITH A BROKEN NAIL. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE. REPORTEDLY THE HELICAL BLADE AND SCREW WERE INTACT. THE SURGEON REPLACED THE TFN CONSTRUCT WITH COMPETITORS BIPOLAR HIP DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45861 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER NAIL HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention