BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE 3X800 MM

    MDR report key: 2212121 · Received July 8, 2011

    Report

    Report Number
    9610622-2011-00305
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    BEFORE THE G3 NAIL SURGERY, WHEN THE PACKAGE OF GUIDE WIRE WAS OPENED, IT WAS FOUND THAT THE PART (MELTED CAP) OF THE PROTECTION CAP ATTACHED TO THE TIP OF GUIDE WIRE. THUS THE SURGEON CHANGED THE GUIDE WIRE TO ANOTHER NEW GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE, BALL-TIPPED, STERILE 3X800 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K137300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other