BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12074726 · Received June 28, 2021

    Report

    Report Number
    12074726
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 15, 2021
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXH
    UDI-DI
    04546540195937
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TIP OF K WIRE BROKE IN 2 PCS, SMALL PIECE( LESS THAN 1 CM) STUCK IN PATIENT'S BONE, OTHER PIECE RETRIEVED. SURGEON UNABLE TO REMOVE PIECE OF K WIRE, DECIDED TO LEAVE IT IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972487 NA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 1806-0085S 04546540195937

    Patients

    Seq Age Sex Outcome Treatment
    1 30660 DA