BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE FOR DIAM 3.5 SCREW

    MDR report key: 2180791 · Received July 7, 2011

    Report

    Report Number
    9615741-2011-00028
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 7, 2011
    Manufacturer
    INTEGRA, SAINT PRIEST
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE USING ADVANSYS LOWER EXTREMITY INSTRUMENTATION, THE SURGEON PUT THE DRILL GUIDE IN, AND THE TOP OF THE DRILL GUIDE BROKE OFF. THERE WAS A LOT OF TORQUE BEING APPLIED AT THE TIME THE BREAKAGE OCCURRED. THERE WAS NO HARM TO THE PT. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO. INTEGRA HAS REQUESTED RETURN OF THE DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL GUIDE FOR DIAM 3.5 SCREW ADVANSYS HTW INTEGRA, SAINT PRIEST

    Patients

    Seq Age Sex Outcome Treatment
    1