BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAL ROD BENDER - LEFT FOR

    MDR report key: 3003376 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10419
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    April 12, 2011
    Report Date
    April 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO IRREGULARITIES WERE FOUND. THE COMPLAINT DEVICE WAS RECEIVED WITH THE TIP BROKEN OFF. THE INSTRUMENT CORRESPONDED TO DRAWINGS AND PROCESSES IN PLACE AT THE TIME OF MANUFACTURE. TOO MUCH FORCE WAS APPLIED TO THE TIP OF THE INSTRUMENT CAUSING IT TO BREAK. A NEW DESIGN SPEC IS CURRENTLY BEING DRAWN UP TO IMPROVE THE STRENGTH OF THE BENDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCOLIOSIS PROCEDURE, THE SURGEON TRIED TO ACHIEVE CORRECTION WHILE THE ROD WAS IMPLANTED IN THE PATIENT BY BENDING A COBALT CHROME ROD IN THE CORONAL PLANE WITH THE CORONAL BENDER LEFT AND CORONAL BENDER RIGHT. UPON BENDING THE ROD, THE CORONAL BENDER-LEFT BROKE AT THE TIP. THE BROKEN TIP WAS RETRIEVED AND THE SURGEON WAS ABLE TO COMPLETE BENDING OF THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86654 CORONAL ROD BENDER - LEFT FOR HXW SYNTHES GMBH T945062

    Patients

    Seq Age Sex Outcome Treatment
    1