BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS MIAMI SI FINAL TIGHTENER

    MDR report key: 4101599 · Received September 19, 2014

    Report

    Report Number
    1526439-2014-11909
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    IT WAS NOTED THAT THE MMSI FINAL TIGHTENER [PRODUCT CODE: 2797-12-600, LOT NO: GM4065502] TIP HAS BEEN WORN AT THE MOST DISTAL END OF THE DEVICE. THIS TYPE OF FAILURE CAN BE INDICATIVE OF NOT FULLY SEATING THE DRIVER IN THE SET SCREW DURING THE FINAL TIGHTENING STEP. A DEVICE HISTORY RECORD REVIEW FOR THE MMSI FINAL TIGHTENER [PRODUCT CODE: 2797-12-600, LOT NO: GM4065502] WAS CONDUCTED IDENTIFYING A LOT RELEASED TO STOCK ON 4/2/14 WITH NO DISCREPANCIES. THE LOT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH COMPLAINT TREND ANALYSIS FOR THE MMSI FINAL TIGHTENER [PRODUCT CODE: 2797-12-600, LOT NO: GM4065502] WAS CONDUCTED ON THE PRODUCT CODE, AS ANY CHANGE TO THE DEVICE WOULD CHANGE THE STRESS PROFILE ON THE TIP. NO SYSTEMIC TREND RESULTING IN THE NEED FOR FURTHER ACTION HAS BEEN IDENTIFIED. THE ROOT CAUSE FOR THE MMSI FINAL TIGHTENER STRIPPING CANNOT BE POSITIVELY IDENTIFIED. HOWEVER, BASED ON THE PRESENTATION OF THE DAMAGE IT MAY BE DUE NOT FULLY SEATING THE DRIVER IN THE SET SCREWS DURING TIGHTENING. AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TREND, THIS COMPLAINT 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

    IT WAS REPORTED THAT DURING THE FINAL SET SCREW TIGHTENING, THE MOSS MIAMI FINAL TIGHTER SEEMED TO BE SLIPPING. IT WAS REPORTED THAT THE DISTAL TIP OF THE INSTRUMENT WAS EXAMINED AND SEEMED TO BE WORN. HOWEVER, FURTHER CLARIFICATION REVEALED THAT THE VERY END OF THE FLUTES ON THE DISTAL TIP OF THE INSTRUMENT WERE MISSHAPEN, INDICATING THAT THE FINAL TIGHTENER TIP HAD STRIPPED DURING USE AND WAS NOT WORN AS ORIGINALLY INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585069 MOSS MIAMI SI FINAL TIGHTENER SCREWDRIVER HXX DEPUY SYNTHES SPINE GM4065502

    Patients

    Seq Age Sex Outcome Treatment
    1