BEUDAMED
    FDA Adverse Event Other Summary report: N

    RECON DRILL BIT

    MDR report key: 1038835 · Received May 2, 2008

    Report

    Report Number
    9680825-2008-00004
    Event Type
    Other
    Date Received
    May 2, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THIS EVENT DOES NOT MEET THE FDA REQUIREMENTS OF MANDATORY REPORTING, AFTER SPEAKING WITH FDA AND IN KEEPING WITH THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATIONS: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JAN 15, 2008, ORTHOFIX SRL HAS DECIDED TO REPORT THIS TYPE OF EVENT ON A VOLUNTARY BASE. THE DEVICE WAS SUBJECTED TO CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. TECHNICAL ANALYSIS PERFORMED ON THE DEVICE SHOWED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO ITS FAILURE. THE METALLOGRAPHIC EXAMINATION OF THE FRACTURE SURFACE OF THE DEVICE SHOWED A BRITTLE FRACTURE WITH INTERGRANULAR MECHANISM CAUSED BY OVERLOAD. INASMUCH AS NO ADD'L INFO HAS BEEN PROVIDED BY THE HOSPITAL ABOUT THE CIRCUMSTANCES OF THE SPECIFIC APPLICATION, IT IS NOT POSSIBLE TO CONDUCT A ROOT CAUSE ANALYSIS AT THIS TIME. ORTHOFIX WILL MONITOR SIMILAR PRODUCTS ON THE MARKET AND REPORT ADD'L INFO ABOUT THIS INCIDENT SHOULD IT BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING SURGERY, THE DISTAL PORTION OF THE DRILL BIT BROKE AND REMAINS IN THE FEMORAL NECK OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECON DRILL BIT RECON DRILL BIT HTW ORTHOFIX SRL 173283 010316

    Patients

    Seq Age Sex Outcome Treatment
    1