BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI GAMMA3® Ø10.5X80MM

    MDR report key: 3994200 · Received August 8, 2014

    Report

    Report Number
    0009610622-2014-00399
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON PLACED THE U-LAG SCREW INTO THE PATIENT BONE. ALTHOUGH THE SURGEON TRIED TO INSERT U-BLADE IN U-LAG SCREW, INSERTION OF U-BLADE WAS DIFFICULT. WHEN THE SURGEON CHECKED U-BLADE, THE BASE OF U-BLADE DEFORMED. WHEN THE SURGEON TRIED TO REMOVE THE U-BLADE IT BROKE AND THE PART OF BLADE REMAINED IN THE LAG SCREW. THE SURGEON REAMED THE BONE LATERAL SIDE AND REMOVED THE BROKEN BLADE. THE SURGEON CHANGED THE LAG SCREW INTO LONG SIZE LAG SCREW, AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467710 U-BLADE SET, TI GAMMA3® Ø10.5X80MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other