BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM QC DI EXTENDED TAB POLYAXIAL SCREWDRIVER

    MDR report key: 4221302 · Received November 3, 2014

    Report

    Report Number
    1526439-2014-12050
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED EXPEDIUM 5.5 DI EXTENDED TAB QUICK-CONNECT DRIVER REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. AS REPORTED, THE BROKEN TIP WAS RETRIEVED ALTHOUGH THE SECOND HALF OF THE TIP WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. THE RESULTS OF FRACTURE ANALYSIS SUGGEST THE DRIVER UNDERWENT A QUASI-STATIC TORSIONAL SHEAR FAILURE STARTING AT THE DRIVER HEX AND IS EXTENDED TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE SPECIFIC PRODUCT CODE FOUND NO RELATED COMPLAINTS ASSOCIATED WITH BROKEN DRIVER TIPS. ALTHOUGH THE ROOT CAUSE OF THE DRIVER TIP BECOMING BROKEN CANNOT POSITIVELY BE DETERMINED, THE ANALYSIS SUGGESTS THAT THE DRIVER UNDERWENT A QUASI-STATIC TORSIONAL SHEAR FAILURE STARTING AT THE DRIVER HEX AND IS EXTENDED TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE EXP. DI SET SCREW 179722000 QUANTITY = 7. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE EXPEDIUM QC EXTENDED TAB POLY SCREWDRIVER BROKE OFF FROM THE INSTRUMENT WHEN THE SURGEON WAS BACKING OUT A SCREW THAT WAS PUT IN TOO FAR PRIOR TO PLACING THE ROD. THE BROKEN TIP WAS RETRIEVED. THE INNER COLLET/SADDLE POPPED OUT OF THE HEAD OF THE EXPEDIUM 6.0 X 45MM DI FAVORED ANGLE SCREW WHEN THE SCREW WAS BEING ADJUSTED. A PLAIN CONCOMITANT DEVICE STRAIGHT SCREWDRIVER WAS USED TO ADJUST THE SCREW. THE DRIVER DID NOT BREAK. HOWEVER, THE SURGEON DID HAVE A HARD TIME LOCATING THE INNER HEAD OF THE SCREW BECAUSE OF THE ANGULATION. THE INNER COLLET/SADDLE OF THE EXPEDIUM 6.0 X 50MM DI FAVORED ANGLE SCREW BECAME PARTIALLY DISLODGED/RAISED WITHIN THE SCREW HEAD BEFORE THE CONCOMITANT DEVICE SET SCREW COULD BE PLACED. HOWEVER, THE SURGEON COULD NOT SEE THIS BECAUSE THE ROD AND TABS WERE IN THE WAY. THEREFORE, SEVERAL CONCOMITANT DEVICE SET SCREWS WERE STRIPPED WHILE TRYING TO SEAT THE ROD. THE DIFFICULTIES RESULTED IN A ONE HOUR DELAY TO THE PROCEDURE. THE FOLLOWING THREE MFG. MEDWATCH REPORTS WILL BE FILED FOR THE ONE DRIVER AND THE TWO EXPEDIUM DI FAVORED ANGLE SCREWS THAT WERE INVOLVED IN THIS EVENT: 1526439-2014-12050; 1526439-2014-12051; 1526439-2014-12052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701784 EXPEDIUM QC DI EXTENDED TAB POLYAXIAL SCREWDRIVER SCREWDRIVER HXX DEPUY SYNTHES SPINE MI27573

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR STRAIGHT SCREWDRIVER, CAT# UNK| EXP. DI SET SCREWS, (B)(4)