BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAVALORA-MORSE STERNAL RETRACTOR

    MDR report key: 4992688 · Received August 7, 2015

    Report

    Report Number
    3007208013-2015-00017
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 3, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SYMMETRY PERFORMED AN IN-HOUSE INVESTIGATION OF THIS DEVICE ((B)(4)) ONCE RECEIVED. THIS PARTICULAR DEVICE ((B)(4)) WAS PURCHASED BY THE HOSPITAL PRIOR TO (B)(6) 2012. THIS DEVICE WAS PART OF THE CODMAN & SHURTLEFF INVENTORY, SYMMETRY SURGICAL DID NOT DIVEST OVER THE CODMAN & SHURTLEFF INSTRUMENT INVENTORY UNTIL (B)(6) 2012. THIS INSTRUMENT WAS SOLD PRIOR TO THE DIVESTURE OF THE INSTRUMENT BUSINESS. THE DEVICE ((B)(4)) WAS EVALUATED UPON RETURN, THERE WAS A "REPAIR" MARKING ON THE DEVICE FROM (B)(6) 2012. THE PIECE THAT CAME APART IS AN ISSUE WITH AN OLDER VERSION OF THIS PRODUCT. IN THE CURRENT DESIGN, THE PIECE THAT CAME APART IS NOW ONE WHOLE PIECE-WHICH MAKES IT POSSIBLE FOR THE DEVICE TO COME APART. CURRENT INVENTORY WAS INSPECTED; ALL DEVICES IN STOCK HAVE THE NEW PATTERN WITH A SOLID PIECE.

    Description of Event or Problem · 1

    STERNAL RETRACTOR CAME APART DURING A PROCEDURE, METAL PIECE MOVED WHILE OPENING THE RETRACTOR, DISLODGING BIOBURDEN ONTO STERILE FIELD. INSTRUMENT DID NOT BREAK. NO HARM TO THE PATIENT AS A RESULT. NO DELAY IN TREATMENT, ANOTHER DEVICE WAS REQUIRED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521545 FAVALORA-MORSE STERNAL RETRACTOR STERNAL RETRACTOR GAD SYMMETRY SURGICAL INC. 50-8090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other