BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSOS

    MDR report key: 11816715 · Received May 13, 2021

    Report

    Report Number
    11816715
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 11, 2021
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) HIP, TIP OF DRILL WAS BROKEN DURING SURGERY. WAS EMBEDDED IN BONE. SURGEON DECIDED KEEP BROKEN TIP IN SITU. NO HARM KNOWN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718242 AXSOS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER TRAUMA SA 705032

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA