BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORTICAL SCREWS

    MDR report key: 2114225 · Received May 16, 2011

    Report

    Report Number
    9680825-2011-00006
    Event Type
    Other
    Date Received
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PATIENT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON (B)(4) 2008, ORTHOFIX SRL DECIDES TO REPORT THIS KIND OF EVENTS, ON A VOLUNTARY BASE. TECHNICAL INVESTIGATION: THE BROKEN SCREW, RECEIVED ON (B)(6), WAS SENT TO AN EXTERNAL LABORATORY FOR CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. THE TECHNICAL ANALYSIS PERFORMED ON THE RETURNED DEVICE EVIDENCES ITS COMPLIANCE WITH ORTHOFIX DESIGN SPECIFICATIONS. THE BREAKAGE OCCURRED IS DUE TO BENDING FATIGUE FAILURE. CLINICAL EVALUATION: THE X-RAYS EVALUATION MADE BY EXTERNAL MEDICAL EVALUATOR, CONFIRMED THAT THE EVENT WAS NOT DEVICE RELATED. THE BREAKAGE IS RELATED TO THE INSUFFICIENT INSERTION OF THE BONE SCREW (ONLY 54% OF THE SCREW THREAD WAS INSIDE THE BONE). THE CLINICAL EVALUATION ALSO EVIDENCED THAT THE BONE SCREWS WERE APPLIED TOO CLOSE TOGETHER, IN A MECHANICALLY INEFFICIENT CONFIGURATION. THESE TWO FACTORS WOULD HAVE BEEN THE REASON FOR THE SCREW BREAKAGE IN THIS PATIENT. ANYWAY, A FRAGMENT OF THE SCREW WAS LEFT IN THE PATIENT'S BONE. THIS DID NOT LEAD TO ANY ADVERSE EFFECTS TO THE PATIENT. THIS IS THE REASON FOR THIS VOLUNTARY REPORTING. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR AN INFECTED AND FRACTURED FEMORAL NECK. THE SURGEON USED THE PELVIC FIXATOR AND ONE SIDE WAS EXCHANGED FOR A PROCALLUS STRAIGHT CLAMP. THE PROCALLUS STRAIGHT CLAMP WAS USED AT THE FEMORAL SIDE. THE SURGEON INSERTED TWO SELF-DRILLING CORTICAL SCREWS INTO ANTERIOR-SUPERIOR ILIAC SPINE AND ANTERIOR-INFERIOR ILIAC SPINE. AT ABOUT 3 MONTHS FROM THE APPLICATION, ONE BONE SCREW WAS BROKEN. THE BROKEN SCREW WAS REPLACED. NO PATIENT EFFECTS WERE REPORTED APART THAT THE BROKEN TIP OF THE SCREW WERE LEFT IN PATIENT BONE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL SCREWS CORTICAL SCREWS JDW ORTHOFIX SRL 10113 G145

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR