BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HEXLOBE DRIVER X15

    MDR report key: 2971996 · Received February 21, 2013

    Report

    Report Number
    1526439-2013-12661
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 5, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DRIVER CONFIRMED DISTAL TIP BREAKAGE. AN OPTICAL IMAGE OF THE FRACTURED SURFACE REVEALED PLASTIC DEFORMATION AND RATCHET MARKINGS STRETCHING IN A CIRCULAR PATTERN AROUND THE CENTER OF THE IMAGE. THIS SUGGESTS THE DRIVER UNDERWENT A STATIC FAILURE DUE TO SHEAR TORSIONAL OVERLOADING WHILE TIGHTENING. SCANNING ELECTRON MICROSCOPY CONFIRMED THAT BREAKAGE LIKELY OCCURRED DUE TO HIGH TORSIONAL SHEAR LOADS. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS INSPECTION OF A RETURNED LOAN KIT FOUND THE TIP OF THE HEXLOBE DRIVER HAD BROKEN OFF FROM THE INSTRUMENT. IT IS NOT KNOWN WHEN/WHERE TIP BREAKAGE OCCURRED. THIS REPORT IS BEING REPORTED LATE. THE NEED TO REPORT MDRS WITHIN THIRTY DAYS OF BECOMING AWARE OF THE EVENT HAS BEEN REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76592 MODULAR HEXLOBE DRIVER X15 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE G0808

    Patients

    Seq Age Sex Outcome Treatment
    1