BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI ? 10.5X100MM

    MDR report key: 1349579 · Received December 22, 2008

    Report

    Report Number
    9610622-2008-00292
    Event Type
    Malfunction
    Date Received
    December 22, 2008
    Date of Event
    December 5, 2008
    Report Date
    December 5, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING G3 SURGERY, THE SURGEON PLACED THE U-LAG SCREW INTO THE PT. THE SURGEON TRIED TO INSERT THE U-BLADE USING THE INSERTER. WHEN THE INSERTER WAS ASSEMBLED WITH THE CONNECTOR, THE TRIGGER OF INSERTER COULD NOT BE PULLED SO THAT THE CONNECTOR CANNOT PROCEED. THUS THE SURGEON HIT THE U-CONNECTOR WITH A HAMMER. THE U-BLADE COULD NOT GO INTO THE U-LAG SCREW. AFTERWARDS, THE TRIGGER OF INSERTER COULD NOT BE PULLED SO THAT THE CONNECTOR COULD NOT PROCEED AGAIN. THE SURGEON REMOVED THE U-BLADE AND CHANGED TO THE STANDARD LAG SCREW AND THE PROCEDURE WAS COMPLETED. AFTER THE SURGERY THE SURGEON FOUND SCRATCH TO THE SHAFT OF U-LAG SCREW AND THE TIP OF U-BLADE DENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE SET, TI ? 10.5X100MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K629470

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other