BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA SCREWDRIVER MODULAR

    MDR report key: 1022806 · Received March 28, 2008

    Report

    Report Number
    1649384-2008-00183
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 28, 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

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. 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 INHIBITING THE RETAINING SHAFT FROM THREADING ONTO THE SCREW HEAD. THE SEQUOIA DRIVERS WERE RECALLED ON 02/13/2008 AND THE DISTRICT OFFICE RECALL AND 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 PART, IT WAS IDENTIFIED THAT THE LEAD THREAD ON THE SCREWDRIVER RETAINING SHAFT IS DEFORMED INHIBITING THE RETAINING SHAFT FROM THREADING ONTO THE SCREW HEAD. THIS MALFUNCTION HAS BEEN PREVIOUSLY REPORTED. ON 08 FEB 2008, THE SALES REP ORIGINALLY REPORTED THAT THE DRIVER WAS NOT WORKING PROPERLY. THIS WAS NOTICED WHILE INSPECTING THE KIT. THERE WAS NO ASSOCIATED PT CONTACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK