BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORTICAL SCREWS

    MDR report key: 2155606 · Received April 29, 2011

    Report

    Report Number
    9680825-2011-00003
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 29, 2011
    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 DID 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 SRL DECIDED TO REPORT THIS KIND OF EVENTS, ON A VOLUNTARY BASE. THE BROKEN SCREWS, RECEIVED ON (B)(4), WERE SENT TO AN EXTERNAL LABORATORY FOR CHEMICAL ANALYSIS. THE TECHNICAL ANALYSIS PERFORMED ON THE RETURNED DEVICES EVIDENCES THEIR COMPLIANCE WITH ORTHOFIX DESIGN SPECS. THE X-RAYS EVAL MADE BY EXTERNAL MEDICAL EVALUATOR, CONFIRMED THAT THE EVENT WAS NOT DEVICE RELATED. THE BREAKAGE IS RELATED TO THE INCORRECT SELECTION OF THE SCREWS SIZE (THE WRONG DIAMETER OF SCREW WAS CHOSEN AND THE WRONG THREAD LENGTH). THE INDICATION FOR THE CORRECT SCREWS SELECTION ARE LISTED IN THE ORTHOFIX LEAFLET PQ EXF: SCREW LENGTH AND THREAD LENGTH SHOULD BE SELECTED IN ACCORDANCE WITH BONE AND SOFT TISSUE DIMENSIONS. THE SCREW THREAD IS CONICAL IN DESIGN AND TAPERS, FOR EXAMPLE, FROM 6.0 TO 5.0 MM BETWEEN THE SHAFT AND THE TIP OF THE STANDARD ORTHOFIX SCREWS, OR FROM 6.0 TO 5.6 MM IN THE XCALIBER SCREWS. THREAD LENGTH SHOULD BE SUCH THAT AT LEAST ONE FULL THREAD WILL REMAIN OUTSIDE THE ENTRY CORTEX AND THE SCREW TIP WILL PROJECT JUST BEYOND THE SECOND CORTEX. SCREW DIAMETER SHOULD BE SELECTED IN ACCORDANCE WITH BONE DIAMETER: FOR A BONE DIAMETER GREATER THAN 20 MM, 6-5 OR 6-5.6 M BONE SCREWS SHOULD BE USED; FOR A BONE DIAMETER BETWEEN 12 AND 20 M, 4.5-3.5 MM BONE SCREWS; AND FOR A BONE DIAMETER BETWEEN 9 AND 12 MM, 3.5-3.2 MM BONE SCREWS SHOULD BE USED. ANYWAY, A FRAGMENT OF THE SCREWS WAS LEFT IN THE PT'S BONE. THIS DID NOT LEAD TO ANY ADVERSE EFFECTS TO THE PT. THIS IS THE REASON FOR THIS VOLUNTARY REPORTING. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET. ADD'L LOT # AND DEVICE MANUFACTURE DATE: G160 AND 10/2010.

    Description of Event or Problem · 1

    AT ABOUT 50 DAYS FROM THE APPLICATION, TWO BONE SCREWS WERE BROKEN. NO PT EFFECTS WERE REPORTED APART THAT THE BROKEN TIPS OF THE SCREWS WERE LEFT IN PT HUMERAL BONE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL SCREWS CORTICAL SCREWS JDW ORTHOFIX SRL 10106 G119

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR