BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREER SEPTUM ELEVATOR

    MDR report key: 1033192 · Received April 23, 2008

    Report

    Report Number
    1226348-2008-00101
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. A VISUAL EXAMINATION REVEALED THAT ONE SIDE OF THE SHAFT IS BROKEN AT APPROX 1/2 INCH FROM THE TIP. THE FRACTURED SURFACE REVEALED EVIDENCE OF CORROSION ON AT LEAST PART OF THE FRACTURE. THIS TYPE OF FRACTURE/BREAKAGE TYPICALLY OCCURS DUE TO USE/WEAR OVER A PROLONGED PERIOD OF TIME (THIS INSTRUMENT IS APPROX 18 YEARS OLD). IT MAY ALSO OCCUR WHEN THERE HAS BEEN A SMALL CRACK IN THE MATERIAL BOUGHT ABOUT BY EITHER OVERLY AGGRESSIVE USE/ABUSE OF THE INSTRUMENT OR THROUGH A MFG ERROR IN THE ORIGINAL SETTING OR BENDING OF THE INSTRUMENT. IT IS NOT POSSIBLE TO DETERMINE HOW THE ORIGINAL CRACK WAS FORMED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT, THEREFORE; IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE FREER ELEVATOR BROKE IN THE PT. CUSTOMER CALLED AND EXPLAINED THAT THE SURGEON NEEDED TO MAKE THE INCISION LONGER AND NEEDED TO USE A C-ARM TO REMOVE THE DEVICE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED AND THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREER SEPTUM ELEVATOR ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY GEG CODMAN & SHURTLEFF, INC. NA 915

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK