BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS SINGLE INNER SETS SCREW

    MDR report key: 3854178 · Received June 6, 2014

    Report

    Report Number
    1526439-2014-11580
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041801
    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

    EXAMINATION OF THE RETURNED MIS SINGLE INNER SET SCREW FOUND THE TEETH ON THE INSIDE WERE NOTICEABLY STRIPPED. ONE SURFACE FEATURES NUMEROUS SCRATCHES AS IF THE SURGEON STRUGGLED TO PROPERLY INSERT A DRIVER AND PLACE IT PROPERLY IN A POLYAXIAL SCREW¿S TULIP HEAD. THE START OF THE THREAD ON THE DAMAGED SIDE FEATURED SOME DAMAGE IN THE FORM OF DEFORMATION/WEAR. THE DAMAGE IS CONSISTENT WITH EXCESS FORCE BEING APPLIED IN ATTEMPT TO FORCE DOWN THE SCREW DURING CROSS-THREADING. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THESE PRODUCTS THAT COULD CONTRIBUTE TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS ON THE PRODUCT CODE FOUND NO SYSTEMIC COMPLAINT TREND WAS IDENTIFIED THAT WOULD REQUIRE FURTHER ACTION. A ROOT CAUSE CANNOT BE DETERMINED FROM THE DEVICE AND INFORMATION PROVIDED. HOWEVER, A POTENTIAL ROOT CAUSE MAY BE AGGRESSIVE INSERTION METHODS LEADING TO THE SET SCREW CROSS-THREADING AND BECOMING DAMAGED DURING INSERTION. NO CORRECTIVE AND PREVENTIVE ACTION IS NECESSARY AT THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO 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 REPORTS THE TAB OF AN INSERTED MIS CANNULATED X-TAB SCREW BROKE OFF FROM THE SCREW DURING SURGERY. THE TAB BREAKAGE WAS NOTED AT THE EXTERNAL LEFT SIDE OF L5 WHEN A CONCOMITANT DEVICE ROD WAS PULLED OUT. THE ROD HAD BEEN INSERTED BUT WAS REMOVED BECAUSE THREADS OF AN MIS SINGLE INNER SET SCREW BECAME CROSS THREADED DURING ASSEMBLY AND THE SET SCREW COULDN¿T BE PLACED PROPERLY. THIS IS WHEN THE TAB WAS BROKE. IT WAS REPORTED THAT THE SCREW AT S1 WAS INSERTED DEEPLY TO THE INNER SIDE AND THE SLEEVE WAS REMOVED TO CHECK THE ROD INSERTION. ANOTHER PRODUCT (SET SCREW) WAS USED TO COMPLETE THE ROD INSERTION. THE THREADS OF A SECOND MIS SINGLE INNER SET SCREW BECAME DEFORMED DURING FINAL TIGHTENING AT RIGHT SIDE OF L5. SURGERY WAS EXTENDED BY SIXTY MINUTES AS A RESULT OF THE CUMULATIVE DIFFICULTIES THAT OCCURRED DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE X-TAB SCREW¿S BROKEN TAB WAS DISCARDED BY THE CUSTOMER. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE ONE MIS CANNULATED X-TAB SCREW AND THE TWO MIS SINGLE INNER SET SCREWS THAT WERE INVOLVED IN THIS EVENT: 1526439-2014-11578, 1526439-2014-11579, 1526439-2014-11580.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331261 MIS SINGLE INNER SETS SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ARFD3B

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD, CATALOG NO. UNK| SLEEVE, CATALOG NO. UNK