BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL PHOENIX TROCHANTERIC 10.5MMX440MM

    MDR report key: 6058425 · Received October 26, 2016

    Report

    Report Number
    0001825034-2016-04280
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    July 30, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK072161
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04280 / 04281 / 03404).

    Description of Event or Problem · 1

    DURING AN ORIF FOR A LEFT SUBTROCHANTERIC FRACTURE, THE GUIDE WIRES WERE NOT ALIGNING WITH THE SCREW HOLES ON THE FEMORAL NAIL. AS A RESULT, ONE OF THE GUIDE WIRES FRACTURED, THE PIECE REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708961 FEMORAL NAIL PHOENIX TROCHANTERIC 10.5MMX440MM ROD, FIXATION HSB BIOMET TRAUMA N/A 243680

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other