BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE KIRSCHNER WIRES MICROAIRE STEINMANN PINS

    MDR report key: 6379823 · Received March 6, 2017

    Report

    Report Number
    6379823
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 22, 2017
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED WITH GRADE 1 OPEN FRACTURE OF THE HAND. DURING SURGERY, K-WIRE FAILURE UPON INSERTION AND BREAKAGE WITHIN THE BONE OF THE PROXIMAL PHALANX. SURGEON MADE ATTEMPTS TO REMOVE FRACTURED KWIRE. SURGEON THAT RISKS OUTWEIGHED THE BENEFITS AND LEFT THE RETAINED WIRE IN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164700 MICROAIRE KIRSCHNER WIRES MICROAIRE STEINMANN PINS PIN, FIXATION, SMOOTH HTY MICROAIRE SURGICAL INSTRUMENTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR