BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2114407 · Received March 24, 2011

    Report

    Report Number
    3004983210-2011-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 24, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    HTW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT A DRILL BIT IN USE IN SURGICAL SITE PREPARATION WAS BROKEN IN USE. A SEGMENT OF THE DRILL BIT TIP, OF UNKNOWN LENGTH, WAS PERMITTED TO REMAIN WITHIN THE BONE. NO ADVERSE IMPACT WAS REPORTED TO THE INTENDED PLACEMENT OF THE ANKLE FUSION PLATE PROSTHESIS UNDERWAY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DRILL BIT IS A CLASS I REUSABLE SURGICAL INSTRUMENT. DEVICE LOT NUMBER HAS NOT BEEN REPORTED. DEVICE RETURN FOR EVALUATION IS ANTICIPATED. THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY LEFT WITHIN THE SURGICAL SITE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER DRILL BIT, 2.7MM DIAMETER HTW TORNIER INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1