BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1883930 · Received October 22, 2010

    Report

    Report Number
    9610667-2010-00010
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    July 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    PMA / PMN Number
    K082120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPPLIED ADAPTER AND UNION SCREW WERE FOUND TO BE OF A PRIOR DESIGN VERSION, MECHANICALLY INCOMPATIBLE WITH CURRENT COMPONENTS. THIRTEEN ADD'L UNITS EXISTED OF THIS DESIGN VERSION, AND ALL WERE REMOVED FROM POTENTIAL DISTRIBUTION. NO FURTHER INFO IS ANTICIPATED IN THIS EVENT.

    Description of Event or Problem · 1

    TORNIER DEVICES WERE SUPPLIED TO A SHOULDER SURGERY INTENDING TO PERFORM/IMPLANT A REVERSE FRACTURE SHOULDER DEVICE. DURING COMPONENT ASSEMBLY, IT WAS SEEN THAT THE SUPPLIED UNION SCREW COMPONENT OF THE ADAPTER COMPONENT WAS INCORRECT IN DIMENSIONS TO MATE WITH THE STEM. THE SURGERY WAS DISCONTINUED AT AN INCOMPLETE STAGE TO DETERMINE THE NATURE OF THE PROBLEM. A REVISION SURGERY WAS REQUIRED AND PERFORMED TO COMPLETE THE IMPLANT ASSEMBLY FOR THIS PT. THE EVENT REPORTED OCCURRED IN (B)(6) WITH A TORNIER DEVICE WHICH IS ALSO (B)(6) DISTRIBUTED. REFERENCE DE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED KWS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R