BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEGIS FINAL TIGHTENER

    MDR report key: 835150 · Received February 14, 2007

    Report

    Report Number
    1526439-2007-00026
    Event Type
    Malfunction
    Date Received
    February 14, 2007
    Date of Event
    January 20, 2007
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED RETURN OF THE AEGIS FINAL TIGHTENER. REVIEW OF THE DEVICE HISTORY RECORD FOUND THE LOT MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. ALTHOUGH THE CAUSE OF TIP BREAKAGE CANNOT BE POSITIVELY DETERMINED AT THIS TIME. THE APPLICATION OF EXCESSIVE FORCE DURING SCREW TIGHTENING CAN RESULT IN DISTAL TIP DAMAGE AND BREAKAGE. A FOLLOW UP MEDWATCH REPORT WILL BE FILE IF THE EVALUATION OF THE INSTRUMENT DETERMINES THAT THE CAUSE OF TIP BREAKAGE IS DIFFERENT FROM THAT NOTED ABOVE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE DISTAL TIP OF AEGIS FINAL TIGHTENER BROKE OFF AND BECAME LODGED IN THE HEAD OF A SCREW DURING SPINAL SURGERY. THE SCREW WAS IMPLANTED ALTHOUGH IT COULD NOT BE FULLY ADVANCED DUE TO THE PRESENCE OF THE BROKEN TIP. AFTER A PERIOD OF TIME, FOLLOWING THE PROCEDURE, IT WAS DISCOVERED THAT THE BROKEN DRIVER TIP HAD SEPARATED FROM THE SCREW HEAD. THE SURGEON BELIEVES THAT FIBROUS TISSUE WILL GROW OVER THE BROKEN TIP AND HAS NO PLANS FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEGIS FINAL TIGHTENER INSTRUMENT, MANUAL, ORTHOPEDIC, SURGICAL LXH DEPUY SPINE, INC. NA 0406MI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other UNIDENTIFIED AEGIS BONE SCREW