BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRONAIL TITANIUM HUMERAL NAIL, STERILE

    MDR report key: 2161918 · Received July 11, 2011

    Report

    Report Number
    9680825-2011-00009
    Event Type
    Injury
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL EVALUATION OF THE BROKEN PRODUCT USED WAS NOT PERFORMED AS THE PRODUCT HAS NOT BEEN MADE AVAILABLE FOR THE INVESTIGATION. A CLINICAL INVESTIGATION OF THE CASE WAS NOT PERFORMED AS NO INFORMATION ABOUT PATIENT CONDITIONS, MEDICAL PROCEDURE AND X-RAYS HAVE BEEN MADE AVAILABLE. CONSIDERING THE EVENT DESCRIPTION, A NAIL WAS BROKEN BUT NO INFORMATION HAS BEEN PROVIDED ON THE ACTUAL PROCEDURE PUT IN PLACE, SUCH AS PRE AND POST OPERATIVE X-RAYS, NOR THE PRODUCT INVOLVED HAS BEEN RETURNED FOR EVALUATION. THEREFORE, IT IS NOT POSSIBLE TO DRAW ANY CONCLUSION WITH REGARDS TO THE COMPLAINED NAIL BREAKAGE. REGARDING ORTHOFIX CENTRONAIL HUMERAL NAILING SYSTEM BREAKAGES, ACCORDING TO OUR TREND RECORDS, THE FAILURE RATE IS 0,05% ((B)(4) 2005 UP TO DATE, INCLUDED THIS ONE). IN CASE FURTHER INFORMATION IS PROVIDED ON THE SPECIFIC APPLICATION OF THE SYSTEM (E.G. X-RAYS) OR ON THE PRODUCT INVOLVED, ORTHOFIX WILL PROMPTLY RE-OPEN THE INVESTIGATION ON THE CASE. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED WITH A CENTRONAIL HUMERAL NAIL, FOR A FEMORAL DIAPHYSEAL FRACTURE, ON (B)(6) 2010. AT THREE MONTHS FROM THE INTERVENTION, DURING AN X-RAY SESSION, IT WAS DETECTED THAT THE NAIL WAS BROKEN. THE PATIENT WAS RE-OPERATED ON (B)(6) 2011 TO REMOVE THE PROXIMAL PART OF THE NAIL, WHILE THE DISTAL PART OF THE DEVICE WAS LEFT IN PATIENT. THE PATIENT IS CURRENTLY IN GOOD HEALTH CONDITION WITH THE FRACTURE HEALED. EVENT NOTIFIED BY THE (B)(6) HOSPITAL TO THE (B)(6) MINISTRY OF HEALTH. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRONAIL TITANIUM HUMERAL NAIL, STERILE CENTRONAIL TITANIUM HUMERAL NAIL, STERILE HSB ORTHOFIX SRL 99-T787230 IT937943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention