BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2151455 · Received June 8, 2011

    Report

    Report Number
    9610667-2011-00013
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 8, 2011
    Manufacturer
    TORNIER, INC.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL SITE PREPARATION FOR A TORNIER SHOULDER PROSTHESIS IMPLANTATION, IT IS REPORTED THAT THE TIP SECTION OF A 6.5MM RASP INSTRUMENT BROKE IN USE WITHIN THE PATIENT BONE AND COULD NOT BE RETRIEVED. IT IS REPORTED THAT THE TOOL SEGMENT WAS LEFT IN-SITU WITH THE SHOULDER STEM COMPONENT OF THE PROSTHESIS CEMENTED IN PLACE ABOVE THE FRAGMENT. THE SHOULDER PROSTHESIS IS REPORTED TO HAVE BEEN SUCCESSFULLY IMPLANTED WITHOUT DIFFICULTY ARISING FROM THE INDWELLING FRAGMENT. THE PROXIMAL SEGMENT OF THE RASP IS EXPECTED TO BE RETURNED FOR EVALUATION. THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY REMAINING IN-SITU FOLLOWING SURGERY. THE RASP IS A CLASS 1 SURGICAL REUSABLE INSTRUMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER 6.5MM BONE RASP, REUSABLE INSTRUMENT KWS TORNIER, INC. 10C320

    Patients

    Seq Age Sex Outcome Treatment
    1