BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS MIAMI SI FINAL TIGHTENER

    MDR report key: 4182228 · Received October 17, 2014

    Report

    Report Number
    1526439-2014-12008
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: JAN-22-2013, MAR-11-2013. EXAMINATION OF THE RETURNED MOSS MIAMI SI FINAL TIGHTENER REVEALED THAT 1MM TO 2MM OF THE DISTAL TIP WAS PLASTICALLY DEFORMED ON A PERPENDICULAR PLANE. THIS DAMAGE IS CONSISTENT WITH A DRIVER THAT WAS ON AXIS BUT WASN¿T FULLY SEATED DURING USE. A REVIEW OF THE DHR IDENTIFIED NO ISSUES THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS WAS PERFORMED AND NO SYSTEMIC TREND WAS IDENTIFIED AS A RESULT OF THE ANALYSIS. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED BASED ON THE PROVIDED INFORMATION OR RETURNED SAMPLE. HOWEVER, THE OBSERVED DAMAGE SUGGESTS THAT THE DRIVER WAS ON AXIS BUT NOT FULLY SEATED DURING USE. 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

    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

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF TWO MOSS MIAMI SI FINAL TIGHTENERS BECAME STRIPPED DURING SET SCREW TIGHTENING DURING SURGERY. IT WAS REPORTED THE RESULTING DELAY TO THE PROCEDURE WAS TEN MINUTES WHILE REPLACEMENT SHAFT WAS SOUGHT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO MOSS MIAMI SI FINAL TIGHTENERS THAT WERE INVOLVED IN THIS EVENT. 1526439-2014-12008; 1526439-2014-12009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662291 MOSS MIAMI SI FINAL TIGHTENER SCREWDRIVER HXX DEPUY SYNTHES SPINE GM3747401

    Patients

    Seq Age Sex Outcome Treatment
    1