BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL KIT FOR HAMMERLOCK 2 SYSTEM

    MDR report key: 5386102 · Received January 22, 2016

    Report

    Report Number
    1649263-2016-00002
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 21, 2016
    Manufacturer
    BIOMEDICAL ENTERPRISES, INC.
    Product Code
    HTY
    PMA / PMN Number
    K133520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HAMMERTOE CORRECTION PROCEDURE. WHILE THE SURGEON WAS PREPARING SITE WITH BROACH, PROXIMAL PHALANX WAS BROKEN. SURGEON USED KWIRE AS FINAL FIXATION WITHOUT FURTHER ISSUES. PATIENT IS EXPECTED TO HAVE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43771 DRILL KIT FOR HAMMERLOCK 2 SYSTEM DK-H2 HTY BIOMEDICAL ENTERPRISES, INC. DK-H2 BMEDK155218

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention