BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2571610 · Received September 3, 2010

    Report

    Report Number
    3004983210-2010-00008
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    May 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    HWC
    PMA / PMN Number
    990804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REPORTED DISCARDED BY CLINICAL FACILITY. RADIOGRAPHS OBTAINED AT THE TIME OF DEVICE IMPLANTATION HAVE BEEN REQUESTED BUT NOT RECEIVED. INTEGRITY OF THE DEVICE AS IMPLANTED CANNOT BE DETERMINED. RADIOGRAPHIC AND PHOTOGRAPHIC IMAGES OBTAINED AT EXPLANTATION SURGERY CONFIRMS DEVICE IS BROKEN IN-SITU, AND SUBSEQUENTLY THAT A SEGMENT OF THE DEVICE COULD NOT BE EXTRACTED AS HAS BEEN REPORTED. THE RADIOGRAPHS DEMONSTRATE NO SIGNIFICANT BONE FUSION HAD OCCURRED AT THE SURGICAL SITE THROUGH WEEK FIVE AFTER IMPLANTATION. ESTABLISHMENT OF BONE FUSION IS CRITICAL TO IMPLANT INTEGRITY BEFORE WEIGHT BEARING IS PERMITTED. THIS IS A KNOWN POSSIBLE CAUSE OF DEVICE FAILURE. NO FURTHER INFORMATION IS ANTICIPATED IN THIS EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANTED TOE JOINT FUSION DEVICE WAS SEEN BY RADIOGRAPH TO BE BROKEN IN-SITU AT SOME TIME POST OPERATIVELY. THE DEVICE WAS PARTIALLY EXPLANTED IN A REVISION SURGERY ABOUT FIVE WEEKS AFTER INITIAL IMPLANTATION. A SEGMENT OF THE DEVICE COULD NOT BE EXTRACTED FROM THE PROXIMAL PHALANX. DEVICE SEGMENTS AS WERE EXTRACTED HAVE BEEN REPORTED AS CLINICALLY DISCARDED. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED OF THE FACILITY BUT HAS NOT BEEN RECEIVED AND IS NO LONGER ANTICIPATED. THE FAILED FUSION DEVICE IS USED, AND HAS BEEN IDENTIFIED, AS TWO PAIRED COMPONENTS: (B)(4), LOT K10660; (B)(4), LOT K08965. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER SCREW, FIXATION, BONE HWC TORNIER INC. STAYFUSE K10660, K08965

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R