BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 K-WIRE ASSY

    MDR report key: 3831999 · Received May 27, 2014

    Report

    Report Number
    0009617544-2014-00234
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURING REVIEW; RESULTS: THE REPORTED K-WIRE BREAKAGE WAS LIKELY DUE TO CANTILEVER FORCES CONTRIBUTING TO AN OVERLOAD AT THE FRACTURE SITE. CONCLUSION: THE CUSTOMER REPORTED EVENT OF A XIA 3 K-WIRE ASSY MAIN BODY FRACTURE WAS CONFIRMED VIA VISUAL INSPECTION. NO OTHER ADVERSE CONSEQUENCES WERE FOUND. THE FRACTURE IS LOCATED ON THE END RIGHT NEXT TO THE KNOB AND POSSIBLY OCCURRED DUE TO CANTILEVER LOAD ON THE KNOB DURING REMOVAL OF THE WIRE. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE CONNECTING PART OF THE INNER WIRE WAS BROKEN WHEN THE SURGEON PULLED OUT THE INNER FROM THE OUTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE CONNECTING PART OF THE INNER WIRE WAS BROKEN WHEN THE SURGEON PULLED OUT THE INNER FROM THE OUTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310785 XIA 3 K-WIRE ASSY IMPLANT-KIRSCHNER WIRE LXH STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1