BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDARTIS 2.0 DRILL BIT / APTUS 2.5

    MDR report key: 22771452 · Received August 11, 2025

    Report

    Report Number
    MW5174305
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 5, 2025
    Manufacturer
    MEDARTIS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 2.0 DRILL BIT BROKEN OFF INTO LEFT ULNA, ALL PIECES RETRIEVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271011 MEDARTIS 2.0 DRILL BIT / APTUS 2.5 BIT, DRILL HTW MEDARTIS, INC. A 3733

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Required Intervention