BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12576054 · Received October 5, 2021

    Report

    Report Number
    12576054
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 23, 2021
    Report Date
    September 23, 2021
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXH
    UDI-DI
    04546540195852
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    K-WIRE BROKE WHILE IN PATIENT IN OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477234 NA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 1806-0050S 04546540195852

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA