BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACKENEY RETRACTOR

    MDR report key: 5019102 · Received July 30, 2015

    Report

    Report Number
    3007208013-2015-00015
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 29, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (ANKENEY RETRACTOR) WAS MARKED AS BEING FROM CODMAN USA. THE MANUFACTURING OF THIS PARTICULAR DEVICE WAS MOVED TO (B)(4) IN 2006. THE DEVICE IS AT LEAST 9 YEARS OLD. THERE ARE NO OTHER DATE CODES OR LOT NUMBERS ETCHED ON THE DEVICE. THE DEVICE WAS EVALUATED IN HOUSE BY SYMMETRY ENGINEER, THE CONCLUSION: DEVICE WAS REVIEWED CLOSELY FOR CRACKS; THERE WERE NO INDICATIONS OF FLAWS OR DEFECTS OF THE MATERIAL. THE HARDNESS OF THE DEVICE WAS MEASURED ON SEVERAL POINTS ON THE DEVICE AND FOUND TO BE OUT SPECIFICATION. THE ARM THAT CRACKED HAS AN EXTRA FINISH AND ROUNDING TO THE END WHICH INDICATES THAT IT HAD BEEN REPAIRED WHICH VOIDS ANY WARRANTY OF THIS DEVICE. THEREFORE, IT HAS BEEN CONCLUDED THAT THE MATERIAL OF THE DEVICE WAS NOT WITHIN THE SPECIFICATION WHICH CAUSED A WEAKNESS IN THE DEVICE AND CAUSED THE DEVICE TO CRACK UNDER STRESS.

    Description of Event or Problem · 1

    THE CHEST RETRACTOR WAS PLACED IN THE STERNUM & DURING SURGERY, AS THE PHYSICIAN CRANKED THE RETRACTOR OPEN, IT WAS DISCOVERED THAT ONE SIDE OF THE RETRACTOR (OUTSIDE OF THE STERNUM) CRACKED PART WAY THROUGH. NO PIECES BROKEN OFF, ONLY CRACKED INSTRUMENT. NO PATIENT HARM. ORIGINAL INTENDED PROCEDURE: CORONARY ARTERY BYPASS GRAFT X3 W/SKELETONIZED LEFT INTERNAL MAMMARY ARTERY, SKELETONIZED RIGHT INTERNAL MAMMARY ARTERY & LEFT RADIAL ARTERY GRAFT. DEVICE FAILED, CRACKED, COULDN'T GET IT TO WORK OR STOPPED WORKING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499246 ACKENEY RETRACTOR DWS SYMMETRY SURGICAL INC. 50-8069

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other