BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL BIT D 4MM - L 310 MM

    MDR report key: 1038836 · Received May 2, 2008

    Report

    Report Number
    9680825-2008-00003
    Event Type
    Other
    Date Received
    May 2, 2008
    Date of Event
    October 25, 2007
    Report Date
    April 30, 2008
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JANUARY 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 ANALYSES. TECHNICAL ANALYSIS PERFORMED ON THE DEVICE SHOWED IT TO BE COMPLIANT WITH ORTHOFIX PRODUCT SPECIFICATIONS. THE METALLOGRAPHIC EXAMINATION OF THE FRACTURE SURFACE OF THE DEVICE SHOWED A BRITTLE FRACTURE WITH INTERGRANULAR MECHANISM. IN AS MUCH AS NO ADD'L INFO HAS BEEN PROVIDED ABOUT THE CIRCUMSTANCES OF THE SPECIFIC APPLICATION, IT IS NOT POSSIBLE TO CONDUCT A ROOT CAUSE ANALYSIS AT THIS TIME. THE ONLY ASSUMPTION THAT COULD BE MADE IS THAT IT IS LIKELY THE DRILL BIT WAS SUBJECTED TO REPEATED BENDING LOADS DURING INSERTION WHICH CAUSED IT TO BREAK. 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

    THE DRILL BIT BROKE DURING APPLICATION IN SURGERY FOR A FRACTURED FEMUR PERFORMED ON (B) (6) 2007. THE EVENT WAS ONLY REPORTED TO THE MFR IN (B) (6) OF 2008. AS WAS CONFIRMED BY PT X-RAYS AND REPORTED TO ORTHOFIX, THE DISTAL PORTION OF THE BROKEN DEVICE REMAINS IN THE FEMUR, BUT IT HAS NOT HAD ANY ADVERSE EFFECT ON THE PT'S HEALING PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT D 4MM - L 310 MM DRILL BIT D 4MM - L 310 MM HTW ORTHOFIX SRL 1100801 013850

    Patients

    Seq Age Sex Outcome Treatment
    1