BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DI FINAL TIGHTENER

    MDR report key: 3071529 · Received April 22, 2013

    Report

    Report Number
    1526439-2013-15706
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    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 INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DI FINAL TIGHTENER FOUND FOUR LUGS BROKEN OFF FROM THE DISTAL TIP OF THE RETURNED DEVICE. IT WAS NOTED UPON FURTHER EXAMINATION THAT THE FRACTURED SURFACES HAD SIGNS OF PLASTIC DEFORMATION IN THE DIRECTION OF TIGHTENING. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. ALTHOUGH THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED, THE NOTED MATERIAL DAMAGE ON THE FRACTURED SURFACES SUGGESTS THAT THE DEVICE UNDERWENT AN UNANTICIPATED LEVEL OF TORSIONAL SHEAR STRESS DURING SCREW TIGHTENING, RESULTING IN TIP FRACTURE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE DISTAL TIP OF THE DI FINAL TIGHTENER BROKE OFF FROM THE INSTRUMENT DURING TIGHTENING OF A SET SCREW. THE BROKEN TIP WAS RECOVERED FROM THE SURGICAL SITE. THE DIFFICULTY RESULTED IN A DELAY TO THE PROCEDURE OF APPROXIMATELY TWENTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172179 EXPEDIUM DI FINAL TIGHTENER DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE 0605NT

    Patients

    Seq Age Sex Outcome Treatment
    1