BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL TIP NEEDLE WITH THREADED CANNULA

    MDR report key: 1673237 · Received April 30, 2010

    Report

    Report Number
    2951580-2010-00053
    Event Type
    Other
    Date Received
    April 30, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 30, 2010
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT RETURNING TO ARTHROCARE FOR INVESTIGATION, NOR WAS A LOT NUMBER PROVIDED BY THE USER FACILITY. THEREFORE, NO DEVICE LOT HISTORY REVIEW OR DEVICE INVESTIGATION CAN BE COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE WHERE AN ARTHROCARE DRILL TIP NEEDLE WITH THREADED CANNULA WAS ALSO BEING USED. WHILE THE DRILL TIP NEEDLE WAS BEING USED ON THE FEMORAL HEAD, THE TIP OF THE METAL CANNULA BROKE OFF INTO THE PATIENT AND REMAINS IN THE PATIENT. THERE IS NO PLAN TO RE-OPERATE TO REMOVE THE TIP AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL TIP NEEDLE WITH THREADED CANNULA CANNULA, SURGICAL, GENERAL & PLASTIC SUR GEA ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other