BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER MINIPOLYAXIAL SCREWDRIVER

    MDR report key: 1834528 · Received September 10, 2010

    Report

    Report Number
    1526439-2010-00131
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 14, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED RETURN OF THE SCREWDRIVER. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE INSTRUMENT AND COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE SCREWDRIVER BROKE OFF DURING SCREW INSERTION. THE SURGEON THEN ATTEMPTED TO INSERT A SCREW OF THE OTHER SIDE OF THE CONSTRUCT (SAME LEVEL) WITH SECOND SCREWDRIVER AND THE TIP OF THAT DRIVER ALSO BROKE OFF. AN ATTEMPT TO REMOVE BOTH DRIVER TIPS WAS UNSUCCESSFUL. BOTH SCREWS WERE FULLY SEATED WITHIN THE SCREW HEADS AND THE SURGEON WAS ABLE TO INSERT THE ROD AND SECURE IT IN PLACE. THE SURGEON STATED THAT THE BROKEN SCREWDRIVER TIPS DID NOT COMPROMISE THE CASE. THE PT WAS REPORTED TO HAVE EXTREMELY HARD BONE. AS AN UNINTENDED PORTION OF THE INSTRUMENT REMAINS IN THE PT, THIS MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THIS EVENT. MFG MEDWATCH REPORT #1526439-2010-00130 IS BEING FILED FOR THE FIRST SCREWDRIVER THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUNTAINEER MINIPOLYAXIAL SCREWDRIVER ORTHOPAEDIC, MANUAL, SURGICAL, INSTRUMENT LXH DEPUY SPINE, INC. NA X0207

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR