BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEGIS SELF-RETAINING SCREW DRIVER

    MDR report key: 1318614 · Received January 12, 2009

    Report

    Report Number
    1526439-2009-00007
    Event Type
    Malfunction
    Date Received
    January 12, 2009
    Date of Event
    December 19, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    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 SELF-RETAINING SCREW DRIVER FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND THE LOT MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, THE SCREW DRIVER TIP BREAKAGE IS MOST LIKELY THE RESULT OF EXCESSIVE FORCE PLACED UPON THE INSTRUMENT DURING SCREW LOOSENING. A FOLLOW UP MEDWATCH REPORT WILL BE FILED IF EXAMINATION OF THE RETURNED SCREW DRIVER FINDS SOMETHING OTHER THAN THAT WHICH IS STATED ABOVE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT WHEN AN AEGIS SCREW WAS BEING REMOVED, IT APPEARED TO CATCH UNDER A SPINAL PLATE. THE TIP OF THE SELF-RETAINING SCREW DRIVER BEING USED TO REMOVE THE SCREW BECAME TWISTED AND THE TIP SHEARED OFF WITHIN THE HEAD OF THE SCREW. THE BROKEN TIP REMAINS WITHIN THE SCREW HEAD IN THE PT WITH THE PT'S CAM LOCKING THE TIP AND SCREW IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEGIS SELF-RETAINING SCREW DRIVER INSTRUMENT, ORTHOPAEDIC, MANUAL SURGICAL HXX DEPUY SPINE, INC. NA 0607MI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLATE| UNIDENTIFIED AEGIS SCREW