BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1579265 · Received January 8, 2010

    Report

    Report Number
    9610667-2010-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 6, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MWB-991 IS A CLASS I SURGICAL INSTRUMENT.

    Description of Event or Problem · 1

    DURING THE INSTALLATION OF THE GLENOID SPHERE OF SHOULDER REPLACEMENT DEVICE, IT IS REPORTED THAT THE REUSABLE SURGICAL SCREWDRIVER TIP (MWB-991) SHEARED OFF IN THE SCREW HEAD. THE TIP SHEAR IS DESCRIBED AS FLUSH WITH THE SCREW HEAD AND THE TIP MATERIAL COULD NOT BE EXTRACTED FROM THE IMPLANT. THIS IS REPORTED AS A MALFUNCTION OF THE SURGICAL INSTRUMENT RESULTING IN AN UNANTICIPATED FOREIGN BODY AT THE IMPLANT SURGICAL SITE. THE SCREWDRIVER TIP IS A 3.5MM HEX DESIGN. THE REMAINDER OF THE INSTRUMENT HAS BEEN RECOVERED AND IS AVAILABLE FOR ANALYSIS. NO PT ADVERSE EFFECT HAS BEEN REPORTED. NO FURTHER PT DATA HAS BEEN RELEASED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER SURGICAL SCREWDRIVER, 3.5MM HEX HXX TORNIER INC. 09B381

    Patients

    Seq Age Sex Outcome Treatment
    1