BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8 TRILOCK SCREWS, HEXADRIVE 7

    MDR report key: 23390713 · Received October 27, 2025

    Report

    Report Number
    MW5177987
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TIP OF SCREWDRIVER FROM THE MEDARTIS LOANER TRAY BROKE OFF IN WOUND. SURGEON RETRIEVED THE BROKEN PIECE. FINAL XR SHOWED NO RETAINED OBJECTS. ALL PIECES SAVED AND GIVEN TO MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793649 2.8 TRILOCK SCREWS, HEXADRIVE 7 SCREW, FIXATION, BONE HWC MEDARTIS INC. A-5850.16/1

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male