BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE HANDLE CHUCK 2-3, 5MM

    MDR report key: 1981637 · Received January 12, 2011

    Report

    Report Number
    9610622-2011-00008
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE T-HANDLE GUIDE WIRE GUIDE, WOULD NOT GRAB AND SECURE THE GUIDE WIRE IN THE OPERATING ROOM. SURGEON HAD TO GO WITHOUT IT DURING A T2 FEMUR (RETROGRADE) AND LATER ASKED US TO REPLACE THE DAMAGED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE HANDLE CHUCK 2-3, 5MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K474801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other