BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE LOCKING NAIL 11X210MM

    MDR report key: 3900189 · Received June 27, 2014

    Report

    Report Number
    0001825034-2014-05697
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 11, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK081243
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "BENDING OR FRACTURE OF THE IMPLANT"

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ANKLE NAIL FIXATION PROCEDURE IN (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED NAIL AFTER PATIENT TRAUMA. ALL FRACTURED FRAGMENTS WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378069 ANKLE LOCKING NAIL 11X210MM ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A 148870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R