BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8 MM PITON KNOTLESS ANCHOR

    MDR report key: 2854133 · Received November 28, 2012

    Report

    Report Number
    3004983210-2012-00015
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 1, 2012
    Manufacturer
    TORNIER INC
    Product Code
    MBI
    PMA / PMN Number
    K091870
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    A 2.8MM PITON BROKE IN HALF AT SOME TIME AFTER BEING INSERTED IN PATIENT SHOULDER. REVISION SURGERY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.8 MM PITON KNOTLESS ANCHOR PITON MBI TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention