BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS MIAMI SI FINAL TIGHTENER

    MDR report key: 3872844 · Received June 13, 2014

    Report

    Report Number
    1526439-2014-11615
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 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

    ADDITIONAL NARRATIVE: 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

    VISUAL INSPECTION OF THE RETURNED (B)(4) FINAL TIGHTENER REVEALED THAT APPROXIMATELY 1MM TO 2MM OF THE DISTAL TIP HAS BEEN PLASTICALLY DEFORMED IN THE DIRECTION OF TIGHTENING. AN ATTEMPT WAS MADE TO ENGAGE THE FINAL TIGHTENER WITH A SAMPLE SET SCREW. HOWEVER, THE DAMAGE ON THE DISTAL TIP PREVENTED THIS FROM OCCURRING. A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS WAS PERFORMED FOR THE PRODUCT CODE AND NO SYSTEMIC COMPLAINT TREND WAS IDENTIFIED THAT WOULD REQUIRE FURTHER ACTION. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED BASED ON THE PROVIDED INFORMATION AND SAMPLE. HOWEVER, THE OBSERVED DAMAGE IS CONSISTENT WITH A DRIVER THAT HAS NOT BEEN FULLY SEATED IN THE SET SCREW DURING FINAL TIGHTENING. IT IS LIKELY THAT THIS TIP DAMAGE PREVENTED THE DRIVER FROM ENGAGING THE SETSCREW AS REPORTED IN THE EVENT DESCRIPTION. NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND. THEREFORE, THE 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

    INTERNATIONAL AFFILIATE HAD REPORTED THAT THE TIP OF THE MOSS MIAMI SI FINAL TIGHTENER DID NOT ENGAGE THE CAP/SET SCREW CORRECTLY. THE FINAL TIGHTENING COULD NOT BE PERFORMED WITH THE INSTRUMENT. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPLANT AND NO DELAY REPORTED. RECEIPT OF THE INSTRUMENT FOR EVALUATION FOUND THAT THE TIP HAD BEEN STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349949 MOSS MIAMI SI FINAL TIGHTENER SCREWDRIVER HXX DEPUY SYNTHES SPINE GM3950201

    Patients

    Seq Age Sex Outcome Treatment
    1 SET SCREW