BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK 2 DRILL BIT

    MDR report key: 4531340 · Received February 18, 2015

    Report

    Report Number
    1649263-2015-00003
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    January 29, 2015
    Report Date
    February 18, 2015
    Manufacturer
    BIOMEDICAL ENTERPRISES, INC.
    Product Code
    HTY
    PMA / PMN Number
    K133520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) YEAR OLD FEMALE WHO UNDERWENT HAMMERTOE CORRECTIONS OF HER SECOND AND THIRD TOES. THE SURGEON INITIALLY DRILLED THE 3RD TOE WITH THE HL2 DRILL BIT. HOWEVER, DURING THE COURSE OF DRILLING THE PROXIMAL PHALANGE SHATTERED. THE SURGEON DID NOT PUT AN IMPLANT INTO THE 3RD TOE BUT TIED IT BACK TOGETHER WITH CURAGE WIRE. NEXT, THE SURGEON DRILLED AND MEASURED THE 2ND TOE AND THEN HE BROACHED THE 2ND TOE BUT COULD ONLY GET THE BROACH APPROXIMATELY 80-90 PERCENT INSERTED INTO THE BONE. THE SURGEON THEN ATTEMPTED TO PUT IN A MEDIUM HL2 IMPLANT BUT IT WOULD NOT GO ALL THE WAY IN. SO THEN HE TRIED USING A SMALL HL2 IMPLANT BUT HAD A DIFFICULT TIME REDUCING THE JOINT AS THERE WAS STILL GAPING AT THE JOINT. THE SURGEON REMOVED THE IMPLANT AND USED ANOTHER MEANS TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116325 HAMMERLOCK 2 DRILL BIT HTY, PIN, FIXATION, SMOOTH, 21 CFR 888.3040 HTY BIOMEDICAL ENTERPRISES, INC. DK H2 BMEDK145135

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention