BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, 300MM

    MDR report key: 1579090 · Received January 4, 2010

    Report

    Report Number
    8031020-2009-00138
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    December 4, 2009
    Report Date
    December 7, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING HANSSON PIN SURGERY, WHEN THE SURGEON INSERTED THE K-WIRE INTO THE PATIENT BONE, TIP OF K-WIRE BROKE. THE K-WIRE WAS BRAND NEW PRODUCT. THEREFORE, THE SURGEON REMOVED BROKEN TIP OF K-WIRE FROM PATIENT BONE. AND, THE SURGEON CHANGED THE K-WIRE TO ANOTHER NEW K-WIRE. THE SURGERY WAS COMPLETED WITHOUT PROBLEM. TO CHANGE THE DIRECTION OF K-WIRE WHILE INSERTING K-WIRE, THE SURGEON MOVED THE K-WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE, 300MM IMPLANT HTY STRYKER OSTEOSYNTHESIS SELZACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other