BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    MDR report key: 3982414 · Received August 6, 2014

    Report

    Report Number
    0009610622-2014-00391
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    (B)(4) GUIDE WIRE WAS USED FOR T2 GTN SURGERY, BECAUSE OF NARROW CANAL, (SMALL DIAMETER FLEXIBLE REAMER CANNOT GO THROUGH WITH (B)(4)) THEN AFTER INSERT 8MM GTN OVER THE 1806-0083S, GUIDE WIRE COULD NOT BE PULL OUT. THE BALL WAS TOO BIG TO PASS THROUGH THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461963 GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other