BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM QUICK-CONNECT SI POLYAXIAL SCREWDRIVER

    MDR report key: 3170488 · Received June 14, 2013

    Report

    Report Number
    1526439-2013-18932
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    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 RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THAT BREAKAGE HAD OCCURRED AT THE DRIVER¿S DISTAL TIP. NO OTHER DEFECTS OR ABNORMALITIES WERE IDENTIFIED. HARDNESS VERIFICATION FOUND THE INSTRUMENT MET HARDNESS SPECIFICATION REQUIREMENTS. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED ON THE FRACTURED SURFACE TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS OF THE DAMAGED SAMPLE. RESULTS ACKNOWLEDGED A PLASTIC DEFORMATION AT THE DRIVER HEX LOBES, INDICATING A TORSIONAL OVERLOAD FAILURE OF WHICH THE TORSIONAL SHEAR MARKING AT THE CENTER OF THE PART FOLLOW A CIRCULAR PATTERN WHICH EXTENDS TO THE CENTER OF THE SHAFT, SUGGESTING THAT THE DRIVER UNDERWENT A QUASI-STATIC SHEAR FAILURE. REVIEW OF THE DEVICE HISTORY RECORD ACKNOWLEDGED THAT NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE, SEM FRACTURE ANALYSIS RESULTS ACKNOWLEDGED A PLASTIC DEFORMATION AT THE DRIVER HEXLOBES, INDICATING A TORSIONAL OVERLOAD FAILURE OF WHICH THE TORSIONAL SHEAR MARKING AT THE CENTER OF THE PART FOLLOW A CIRCULAR PATTERN WHICH EXTENDS TO THE CENTER OF THE SHAFT. THIS SUGGESTS THAT THE DRIVER UNDERWENT A QUASI-STATIC SHEAR FAILURE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INSPECTION OF A RETURNED LOAN KIT FOUND THE TIP OF THE POLYAXIAL SCREWDRIVER HAD BROKEN OFF FROM THE INSTRUMENT. IT IS NOT KNOWN WHEN OR WHERE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271595 EXPEDIUM QUICK-CONNECT SI POLYAXIAL SCREWDRIVER SCREWDRIVER HXX DEPUY SYNTHES SPINE 0111MI

    Patients

    Seq Age Sex Outcome Treatment
    1