BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAVALORO-MORSE STERN RET

    MDR report key: 1570565 · Received December 22, 2009

    Report

    Report Number
    1226348-2009-00352
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    November 2, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    MDM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. ONE OF THE BLADES IS BROKEN OFF AND THE SCREW THAT HOLDS THE BLADE TO THE RETRACTOR ARM IS FRACTURED. DURING THE EVAL, EXCESSIVE CORROSION WAS FOUND ON THE FRACTURED SURFACES OF THE SCREW. THIS TYPE OF BREAKAGE TYPICALLY OCCURS WHEN THERE HAS BEEN A SMALL CRACK IN THE MATERIAL BROUGHT ABOUT BY EITHER OVERLY AGGRESSIVE USE OF THE INSTRUMENT OR THROUGH A MANUFACTURING ERROR IN THE ORIGINAL SETTING OR BENDING OF THE INSTRUMENT. SUBSEQUENT CORROSION AND STRESSING OF THE CRACKED SITE APPEARS TO HAVE BROUGHT ABOUT THE FAILURE NOTED. IT IS NOT POSSIBLE TO DETERMINE HOW THE ORIGINAL CRACK WAS FORMED. THERE IS NO EVIDENCE OF METALLURGIC DEFECTS (CORROSION) ON ANY OTHER COMPONENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE OF THIS PRODUCT CODE; THEREFORE, IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    MEDWATCH REPORT EXPLAINED THAT THE RETRACTOR PLACED IN PATIENT CHEST AND AS HANDLE WAS RETURNED TO RETRACT, ONE OF THE BLADES FELL OFF DUE TO MATERIAL FAILURE OF THE SCREW HOLDING THE BLADE TO THE RETRACTOR. ADDITIONAL INFO FROM THE CUSTOMER EXPLAINED THAT THE BLADE AND SCREW WERE RECOVERED IMMEDIATELY AND THERE WAS NO DELAY OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAVALORO-MORSE STERN RET MANUAL SURGICAL INSTRU FOR GENERAL USE MDM CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR