BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER, T10 HEXALOBE

    MDR report key: 1973541 · Received January 31, 2011

    Report

    Report Number
    1220246-2011-00010
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. VISUAL EVALUATION OF THE RETURNED DRIVER REVEALED ITS HEXALOBE TIP BROKE OFF. BROKEN PORTION NOT RETURNED. BROKEN ENDS HAVE SIGNS OF TORSIONAL FAILURE. NO OTHER ANOMALIES OBSERVED. THE DEVICE MET ALL DIMENSIONAL SPECIFICATIONS AS RECEIVED. COMPLAINANT'S EVENT TYPICALLY CAUSED BY CONTINUALLY APPLYING TORQUE AFTER THE SCREW IS FULLY SEATED, TORQUING WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, TORQUING WHILE LEVERAGING THE DEVICE. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TIP OF DRIVER BROKE OFF IN SCREW DURING TIGHTENING. NOT RETRIEVED FROM PATIENT. ANKLE FX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER, T10 HEXALOBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other