BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR SHOULDER, PROSTHESIS INTRODUCER

    MDR report key: 3040344 · Received March 8, 2013

    Report

    Report Number
    3008021110-2013-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 8, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR THE BROKEN INSTRUMENT IN ORDER TO ANALYZE IT. IN THE MEANTIME, WE COULD CHECK THE DHR OF THE BATCH INVOLVED (201201195), WITHOUT FINDING ANY ANOMALY. WE WILL SEND AN ADDITIONAL REPORT AS SOON AS WE RECEIVE THE INSTRUMENT AND COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE LUGS OF THE SMR PROSTHESIS INTRODUCER BROKE OFF WHILST BEING USED TO IMPACT THE IMPLANT DURING SURGERY. NO FURTHER INFO IS AVAILABLE. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100535 SMR SHOULDER, PROSTHESIS INTRODUCER KWT, HSD KWT LIMACORPORATE S.P.A. 9013.02.320 201201195

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Hospitalization