BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER

    MDR report key: 12745354 · Received November 2, 2021

    Report

    Report Number
    MW5105111
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 11, 2021
    Report Date
    October 18, 2021
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY ONE OF THE K-WIRES BEING USED REF. 1210-6450S, LOT K04043F, EXP. 2026-06-20 BROKE OFF AND LODGED INTO THE LEFT HIP BONE. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE. STRYKER REPRESENTATIVE (B)(6) WAS PRESENT DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635207 K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH 1210-6405S K04043F

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR