BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAL ROD BENDER-RIGHT FOR

    MDR report key: 3003463 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10416
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE FAILURE MODE AND LOCATION OF THE FAILURE WERE DUPLICATED ON A NEW BENDER FROM INVENTORY IN CADAVER LAB AND BENCHTOP SETTINGS. MATERIAL ANALYSIS INDICATED THAT THE WELDING PROCESS WAS MAKING THE MATERIALS MORE BRITTLE AND LESS TOUGH THAN THEY WOULD BE IN THEIR TYPICAL FORMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR THORACIC FUSION FIXATION PROCEDURE, THE TIP OF THE BENDER BROKE OFF. THE PIECE WAS RETRIEVED. THE SURGEON SELECTED ANOTHER INSTRUMENT AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87010 CORONAL ROD BENDER-RIGHT FOR HXW SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1