BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANNULATED TROCHANTERIC FIXATION NAIL

    MDR report key: 1915707 · Received November 29, 2010

    Report

    Report Number
    1719045-2010-00349
    Event Type
    Injury
    Date Received
    November 29, 2010
    Report Date
    September 24, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE DATE OF MANUFACTURE FROM REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH CANNULATED TROCHANTERIC FIXATION NAIL FOR A PROXIMAL LEFT FEMUR FRACTURE. FOLLOW UP X-RAYS SHOWED THE NAIL TO BE BROKEN. NAIL WAS REMOVED (B)(6) 2010 AND PATIENT REVISED TO ANOTHER INTRAMEDULLARY DEVICE. REPORTEDLY, PATIENT IS OBESE AND AMBULATED EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM/130 DEG TI CANNULATED TROCHANTERIC FIXATION NAIL TROCHANTERIC FIXATION NAIL HSB SYNTHES MONUMENT NA 6377274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention