BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSOS

    MDR report key: 16435126 · Received February 24, 2023

    Report

    Report Number
    16435126
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    December 24, 2022
    Report Date
    February 7, 2023
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRILL TRIP WAS BROKEN AND REMAINED TO PATIENT LEFT TIBIA DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859429 AXSOS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR HWE STRYKER TRAUMA SA 703586

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA Male