BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR X25 HEXLOBE TORQ DRIVR

    MDR report key: 3130427 · Received May 24, 2013

    Report

    Report Number
    1526439-2013-17644
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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 FINAL TIGHTENER CONFIRMED DISTAL TIP BREAKAGE. THE BROKEN TIP PORTION WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED 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. FRACTURE ANALYSIS FOUND EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR FAILURE STARTING AT THE HEX LOBES AND EXTENDING TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE COMPLAINT TRENDS FOUND NO OTHER COMPLAINTS FOR PRODUCTION LOT G0910. ALTHOUGH THE CAUSE OF TIP BREAKAGE CANNOT BE POSITIVELY DETERMINED, AS NOTED, THE FRACTURE ANALYSIS FOUND EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR FAILURE STARTING AT THE HEXLOBES AND EXTENDING TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. IN THE ABSENCE OF AN IDENTIFIED MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    DURING REVISION SURGERY FOR INFECTION THAT WAS NOT ATTRIBUTED TO THE IMPLANTED DEVICES, THE TIPS OF TWO MOSS MIAMI FINAL TIGHTENERS BROKE OFF FROM THE INSTRUMENTS WHEN TRYING TO LOOSEN SET SCREWS FOR REMOVAL. THREE SET SCREWS WERE FINALLY LOOSENED. HOWEVER, ONE SET SCREW WAS SO TIGHT THAT A HIGH SPEED METAL CUTTING BURR WAS USED TO CUT AND REMOVE THE SCREW. THIS MFG MEDWATCH REPORT IS BEING FILED FOR THE SECOND MOSS MIAMI FINAL TIGHTENER WITH A BROKEN TIP. SEE MFG MEDWATCH REPORT NO. 1526439-2013-17643, FOR THE FIRST MOSS MIAMI FINAL TIGHTENER THAT WAS INVOLVED IN THIS EVENT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-17648, FOR THE SET SCREW THAT REQUIRED THE HIGH SPEED METAL CUTTING BURR TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231356 MODULAR X25 HEXLOBE TORQ DRIVR DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE G0910

    Patients

    Seq Age Sex Outcome Treatment
    1