BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORTICAL SCREW

    MDR report key: 2814840 · Received December 2, 2010

    Report

    Report Number
    9680825-2010-00006
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    September 20, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORT, AS THERE ARE NO ADVERSE EFFECTS ON PT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON (B)(4) 2008, ORTHOFIX (B)(4) DECIDES TO REPORT THIS KIND OF EVENTS, ON A VOLUNTARY BASE. THE BROKEN SCREW, RECEIVED ON (B)(4), WAS SENT TO AN EXTERNAL LAB FOR CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. THE TECHNICAL ANALYSIS PERFORMED ON THE RETURNED DEVICE EVIDENCED ITS COMPLIANCE WITH ORTHOFIX DESIGN SPECIFICATIONS. THE X-RAYS EVALUATION MADE BY EXTERNAL MEDICAL EVALUATOR, CONFIRMED THAT THE EVENT WAS NOT DEVICE RELATED. THE BREAKAGE IS RELATED TO THE ERRONEOUS SELECTION OF THE SCREW SIZE. ANYWAY, A FRAGMENT OF THE SCREW WAS LEFT INSIDE THE PT, AS IT WAS DEEMED THE BEST SURGICAL CHOICE BY THE SURGEON. THIS DID NOT LEAD TO ANY ADVERSE EFFECTS TO THE PT. THIS IS THE REASON FOR THIS VOLUNTARY REPORTING. (B)(4), (BONE SCREWS SHAFT DIAMETER 6 MM THREAD DIAMETER 4.5-3.5 MM). ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    AT ABOUT THREE MONTHS FROM THE APPLICATION, X-RAYS WERE TAKEN BEFORE THE FIXATION SYSTEM REMOVAL, AND IT WAS FOUND THAT A BONE SCREW WAS BROKEN. NO PT EFFECTS WERE REPORTED APART THAT THE BROKEN TIP OF THE SCREW WAS LEFT IN PT HUMERAL BONE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL SCREW CORTICAL SCREW JDW ORTHOFIX SRL 10138 G066

    Patients

    Seq Age Sex Outcome Treatment
    1