BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS MIAMI SI FINAL TIGHTENER

    MDR report key: 4185819 · Received October 20, 2014

    Report

    Report Number
    1526439-2014-12011
    Event Type
    Malfunction
    Date Received
    October 20, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MAR 29, 2007, APR 5, 2007, APR 12, 2007, MAY 18, 2007, MAY 25, 2007. THE MMSI FINAL TIGHTENER WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PHOTO WAS PROVIDED. EXAMINATION OF A PHOTO IDENTIFIED THAT APPROXIMATELY 0.5MM IN AXIAL LENGTH THAT THE DRIVER¿S DISTAL TIP HEXLOBES HAD BECOME STRIPPED. ALSO, THE OBSERVED DAMAGE NOTES THAT IT IS IN THE DIRECTION OF TIGHTENING. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. AS SUCH, PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE PRODUCT CODE FOUND NO EMERGING TRENDS. THE ROOT CAUSE OF THE FINAL TIGHTENER BECOMING STRIPPED CANNOT POSITIVELY BE DETERMINED. HOWEVER, ONE POSSIBLE CAUSE FOR THIS FAULT MAY LIKELY BE THAT THE DRIVER WAS NOT FULLY SEATED IN THE SETSCREW DURING THE TIGHTENING STEP. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE HAD REPORTED THAT T8-L1 INSTRUMENTATION WITH EXPEDIUM SYSTEM WAS PERFORMED FOR THE PATIENT WITH OYL. DURING FINAL TIGHTENING OF A SETSCREW, THE TIP OF THE MOSS MIAMI SI FINAL TIGHTENER WAS WORN OUT. THE BACKUP DRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT. THE AFFILIATE WAS ASKED TO CONFIRM THAT FINAL TIGHTENER TIP IS WORN AND NOT STRIPPED. PHOTO RECEIVED FROM THE AFFILIATE IS INDICATIVE OF INTRA-OPERATIVE STRIPPING OF THE INSTRUMENT¿S TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665449 MOSS MIAMI SI FINAL TIGHTENER SCREWDRIVER HXX DEPUY SYNTHES SPINE G0207

    Patients

    Seq Age Sex Outcome Treatment
    1