BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS MIAMI SI FINAL TIGHTENER

    MDR report key: 4232420 · Received November 6, 2014

    Report

    Report Number
    1526439-2014-12065
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 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

    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.

    Additional Manufacturer Narrative · 1

    THE MMSI FINAL TIGHTENER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT APPROXIMATELY 1MM TO 2MM OF THE DISTAL TIP HAD BECOME STRIPPED. THIS DAMAGE IS CONSISTENT WITH A DRIVER THAT WAS ON AXIS BUT WASN¿T FULLY SEATED DURING USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO SYSTEMIC ISSUE THAT REQUIRES FURTHER ACTION. THE ROOT CAUSE FOR THE STRIPPING CANNOT BE POSITIVELY DETERMINED HOWEVER THE DAMAGE IS CONSISTENT WITH A DRIVER THAT WASN¿T FULLY SEATED. NO ISSUE WAS IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO SYSTEMIC TRENDS HAVE BEEN IDENTIFIED. THEREFORE, 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.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF ONE MOSS MIAMI SI FINAL TIGHTENER WAS FOUND TO BE ALREADY STRIPPED WHEN OPENED AND THE TIPS OF TWO ADDITIONAL MOSS MIAMI SI FINAL TIGHTENERS BECAME STRIPPED DURING SURGERY. ADDITIONAL FINAL TIGHTENERS WERE AVAILABLE FOR USE. THE RESULTING DELAY WAS FIVE MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. REGARDING THE FINAL TIGHTENER THAT WAS ALREADY STRIPPED, IT IS NOT KNOWN WHEN/WHERE STRIPPING OF THE TIP OCCURRED. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE THREE FINAL TIGHTENERS. 1526439-2014-12063; 1526439-2014-12064; 1526439-2014-12065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715345 MOSS MIAMI SI FINAL TIGHTENER SCREWDRIVER HXX DEPUY SYNTHES SPINE GM3747401

    Patients

    Seq Age Sex Outcome Treatment
    1