BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTUS 2.5/2.8 SCREWDRIVER

    MDR report key: 22877423 · Received August 22, 2025

    Report

    Report Number
    MW5175137
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 12, 2025
    Report Date
    August 15, 2025
    Manufacturer
    MEDARTIS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDARTIS SCREW DRIVER TIP BROKE DURING PROCEDURE, ALL PIECES RECOVERED, PIECES KEPT TO GIVE TO MANAGEMENT. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872048 APTUS 2.5/2.8 SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDARTIS INC. A-2013 14122376

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male