BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA SCREWDRIVER MODULAR

    MDR report key: 1022627 · Received March 31, 2008

    Report

    Report Number
    1649384-2008-00182
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Removal / Correction Number
    1649384-02/13/08-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE PART MET SPECIFICATION. VISUAL AND FUNCTIONAL EXAMINATION INDICATES THE LEAD THREAD ON THE SCREWDRIVER RETAINING SHAFT IS DEFORMED. FUNCTIONAL TESTING FOUND THE DEFORMATION INHIBITS THE RETAINING SHAFT FROM TREADING ONTO THE SCREW HEAD. THE SEQUOIA DRIVERS WERE RECALLED ON 02/13/2008 AND THE DALLAS DISTRICT OFFICE RECALL & EMERGENCY COORDINATOR WAS NOTIFIED OF THE ACTIONS TAKEN ON 02/19/2008. FURTHER INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    ON 28 MAR 2008, AFTER REVIEWING THE PRODUCT RETURNED FOR INVESTIGATION, IT WAS IDENTIFIED THAT THE LEADING THREAD OF THE DRIVER IS DEFORMED ON THE RETAINING SHAFT. ON A MONTH PRIOR, THE SALES REPRESENTATIVE HAD PREVIOUSLY REPORTED THAT THE DRIVER WAS NOT WORKING PROPERLY WHEN INSPECTING THE KIT. THIS MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA SCREWDRIVER MODULAR SEQUIOA HXX ABBOTT SPINE 47PY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK