BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS CROSS CONNECTOR PLUG DRIVER

    MDR report key: 5964926 · Received September 20, 2016

    Report

    Report Number
    0009617544-2016-00369
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 25, 2016
    Report Date
    August 26, 2016
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    UDI-DI
    07613327276305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 133907. VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA VISUAL INSP. MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO (1) OVERLOADING FROM THE USER'S CANTILEVER FORCE ON THE TIP OF THE INSTRUMENT BASED ON THE ASYMMETRIC DAMAGE; (2) NORMAL WEAR AND HIGH FREQUENCY USAGE - THE PRODUCT AGE OF 3+YEARS AND SIGN OF WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; DURING SURGERY, THE TIP OF THE 2 DRIVERS BROKE WHEN THE SURGEON USED THEM TO FASTEN THE 20MM CROSS CONNECTOR. FINALLY, THE SURGEON DID NOT USED THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; DURING SURGERY, THE TIP OF THE 2 DRIVERS BROKE WHEN THE SURGEON USED THEM TO FASTEN THE 20MM CROSS CONNECTOR. FINALLY, THE SURGEON DID NOT USED THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616942 RADIUS CROSS CONNECTOR PLUG DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE 133907 07613327276305

    Patients

    Seq Age Sex Outcome Treatment
    1