BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2576951 · Received July 1, 2010

    Report

    Report Number
    3004983210-2010-00006
    Event Type
    Malfunction
    Date Received
    July 1, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    HTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE USING A REUSABLE SURGICAL TOOL, A COUNTERSINK REAMER 6.5MM DIAMETER, TO PREPARE AN ORTHOPEDIC SCREW HOLE IN BONE, A SEGMENT OF THE TIP OF THE REAMER WAS BROKEN OFF. IT WAS NOT RECOGNIZED AS BROKEN AT THE TIME AND THE TIP OF THE REAMER IS BELIEVED REMAINING WITHIN THE PATIENT AT THE SURGICAL SITE. NO PATIENT HEALTH ISSUES HAVE BEEN REPORTED. THE TOOL LOT NUMBER HAS NOT YET BEEN IDENTIFIED. THE TOOL HAS BEEN RECOVERED FOR EXAMINATION. THE TOOL MATERIAL IS NOT QUALIFIED/VALIDATED AS IMPLANT GRADE, THEREFORE THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY POSSIBLY REMAINING IMPLANTED. THE TOOL IS A CLASS 1 SURGICAL INSTRUMENT WITHOUT 510K NUMBER ASSOCIATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER INSTRUMENT, 6.5MM COUNTERSINK REAMER HTO TORNIER INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other