BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1953865 · Received December 2, 2010

    Report

    Report Number
    9610667-2010-00016
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 2, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE TIGHTENING THE SCREW OF AN ULNAR CAP COMPONENT OF A NEW ELBOW PROSTHESIS, THE TIP OF THE 3.5 MM SCREWDRIVER TIP BROKE OFF AND REMAINS WITHIN THE SCREW HEAD. NO PATIENT INJURY IS REPORTED. THE SCREWDRIVER IS A CLASS 1 SURGICAL INSTRUMENT. THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY LEFT IN-SITU. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER SCREWDRIVER, 3.5 MM KWS TORNIER INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR