BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT CALIBRATED 200MM

    MDR report key: 23196566 · Received October 1, 2025

    Report

    Report Number
    3011656326-2025-00006
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 1, 2025
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HTW
    PMA / PMN Number
    K152000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE DEVICE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING AN ORIF ANKLE PROCEDURE, A 110040 2.5MM DRILL BIT CALIBRATED 200MM WAS UTILIZED AND THE DRILL BIT BROKE. THE BROKEN FRAGMENT WAS LEFT IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459002 2.5MM DRILL BIT CALIBRATED 200MM 2.5MM DRILL BIT CALIBRATED 200MM HTW OSTEOCENTRIC TECHNOLOGIES, INC. 110040

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other