BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSOS

    MDR report key: 9595683 · Received January 16, 2020

    Report

    Report Number
    9595683
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 24, 2019
    Report Date
    January 3, 2020
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    HWC
    UDI-DI
    04546540694089
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A TIBIAL PLATEAU FRACTURE OPEN REDUCTION INTERNAL FIXATION, TWO DRILL BITS BROKE INSIDE THE PATIENT'S TIBIA. BROKEN DRILL BITS LEFT INSIDE THE PATIENT'S BONE AS IT WOULD REQUIRE SIGNIFICANT EFFORT AND LIKELY CAUSE MORE HARM TO REMOVE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58304 AXSOS SCREW, FIXATION, BONE HWC STRYKER TRAUMA SA 703586 04546540694089

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA Other