BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, RECON 3.2 X 400 MM

    MDR report key: 1030804 · Received April 17, 2008

    Report

    Report Number
    9610622-2008-00042
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING T2 RECON NAIL SURGERY, THE TIP OF K-WIRE BROKEN INSIDE THE FEMORAL BONE, AND THE SURGEON COULD NOT REMOVE THE TIP OF THE K-WIRE. THE LENGTH OF THE BROKEN TIP IS ABOUT 5MM. THE SURGEON USED ANOTHER NEW K-WIRE, AND THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, RECON 3.2 X 400 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other