BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT STARTER AWL

    MDR report key: 744333 · Received August 3, 2006

    Report

    Report Number
    1526439-2006-00180
    Event Type
    Injury
    Date Received
    August 3, 2006
    Date of Event
    July 6, 2006
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HXX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL INSPECTION OF THE RETURNED STARTER AWL FOUND THE DEVICE MET SPEC REQUIREMENTS. IT APPEARS THAT, THE CUSTOMER USED THE INCORRECT INSTRUMENT IN PREPARING THE BONE FOR SCREW INSERTION. HOWEVER, DEPUY SPINE HAS REQUESTED ADD'L INFO/CLARIFICATION FROM THE AFFILIATE. A F/U MEDWATCH REPORT WILL BE FILED IF IT IS DETERMINED THAT THE DIFFICULTY WAS CAUSED BY SOMETHING OTHER THAN THAT WHICH IS STATED ABOVE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS, THE DIAMETER OF THE AWL IS OVERSIZED. IT IS REPORTED THAT AS A RESULT, A PEDICLE BROKE OUT THROUGH THE HOLE THAT WAS CREATED BY THE AWL AND A SCREW THAT WAS BEING IMPLANTED HAD NO FIXATION. A SECOND SCREW WAS TRIED AND ALSO COULD NOT BE SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT STARTER AWL ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT HXX DEPUY SPINE, INC. NA F0904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention