BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOSTEOTITE BONE SCREW 200/50 MM SHAFT D 6 MM

    MDR report key: 2997341 · Received March 5, 2013

    Report

    Report Number
    9680825-2013-00004
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HWC
    PMA / PMN Number
    K974186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. (B)(4). ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST BREAKAGE NOTIFIED ON THIS SPECIFIC DEVICE LOT. TECHNICAL EVAL: THE THIRD BROKEN SCREW (ALSO REFERRED TO AS SCREW C) WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA AND THEN IMMEDIATELY SENT TO AN EXTERNAL LAB FOR CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. THE RESULTS OF THE TECHNICAL INVESTIGATION EVIDENCED THAT THE RETURNED SCREW WAS ORIGINALLY CONFORMING TO ORTHOFIX SRL DESIGN SPECIFICATION. THE DEVICE BROKE DUE TO FATIGUE BENDING FAILURE. CLINICAL EVAL: OVERALL CASE. PLEASE KINDLY REFER TO THE ATTACHED FILE, RE ATTACHMENT TO MFR REPORT 9680825-2013-00004 - CLINICAL EVALUATION SUMMARY. FINAL CONCLUSION: BASED ON THE RESULTS OF THE TECHNICAL INVESTIGATION PERFORMED ON THE RETURNED SCREW AND ON THE EVIDENCE DERIVING FROM THE CLINICAL EVAL, ORTHOFIX SRL CAN CONCLUDE THAT THE BREAKAGE THAT OCCURRED IS NOT DEVICE RELATED. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    ON 02/06/2013, ORTHOFIX SRL RECEIVED INFORMATION FROM THE (B)(6) DISTRIBUTOR THAT A THIRD SCREW BREAKAGE OCCURRED IN RELATION TO THE COMPLAINT NUMBER (B)(4). ON 02/25/2013, ORTHOFIX SRL WAS INFORMED THAT THE FIXATOR WAS REMOVED TOTALLY. (B)(4). PLEASE KINDLY REFER ALSO TO THE MFR REPORT NUMBERS 9680825-2012-00006 AND 9680825-2012-00007 AND RELEVANT FOLLOW-UP REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93672 OOSTEOTITE BONE SCREW 200/50 MM SHAFT D 6 MM OOSTEOTITE BONE SCREW 200/50 MM SHAFT D 6 MM HWC ORTHOFIX SRL 99-60115 11001480

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention