BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DI POLYAXIAL SCREWDRIVER

    MDR report key: 1658715 · Received April 12, 2010

    Report

    Report Number
    1526439-2010-00055
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    March 16, 2010
    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 THE RETURN OF THE POLYAXIAL SCREWDRIVER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT WHEN THE SURGEON WAS ADVANCING THE POLYAXIAL SCREW, THE TIP OF THE SCREWDRIVER SHEARED OFF WITHIN THE SCREW HEAD. THE BROKEN TIP COULD NOT BE RETRIEVED AND IS LODGED WITHIN THE HEAD OF THE TIGHTENED SCREW. A ROD PLACED ON TOP OF THE SCREW ENSURES THAT THE TIP WILL NOT MIGRATE. AS AN UNINTENDED PORTION OF THE SURGICAL INSTRUMENT REMAINS IN THE PT, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM DI POLYAXIAL SCREWDRIVER INSTRUMENT, ORTHOPAEDIC, MANUAL, SURGICAL HXX DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNIDENTIFIED POLYAXIAL SCREW