BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTUS 2.0 TWIST DRILL BIT

    MDR report key: 22755148 · Received August 8, 2025

    Report

    Report Number
    MW5174277
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 4, 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

    WHILE PERFORMING THE PROCEDURE, A DRILL BIT WAS BEING USED ON THE PATIENT AND THE TIP OF IT BROKE OFF IN THE LEFT ARM. THE DRILL BIT WAS LOCATED AND REMOVED; X-RAY WAS TAKEN TO VERIFY PIECES WERE ALL REMOVED. SUPERVISOR WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914034 APTUS 2.0 TWIST DRILL BIT BIT, DRILL HTW MEDARTIS INC. A 3434 12110332

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention