BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR INNER SCREW

    MDR report key: 3677518 · Received March 13, 2014

    Report

    Report Number
    1526439-2014-11383
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK042508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATES: 07/20/2013; 07/02/2013; 07/13/2013; 07/01/2013; 07/28/2013; 07/01/2013; 05/29/2013. 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 VERIFICATION INDICATED THAT THE THREADS ON THE INNER SCREWS HAD BEEN TORN. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE MOUNTAINEER HEAD TO HEAD X-CONNECTOR INNER SCREW FOUND NO DISCREPANCIES DURING THE MANUFACTURING OF THE PRODUCT. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPANYING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE MOUNTAINEER HEAD TO HEAD X-CONNECTOR INNER SCREW WAS CONDUCTED ON THE SPECIFIC PRODUCT CODE FROM THIS COMPLAINT AS THE PRODUCT FAMILY DOES NOT EXIST FOR THIS DEVICE. IT WAS NOTED THAT THERE WAS NO HARM TO THE PATIENT BUT POTENTIAL MAY EXIST IF THE FAULT WERE TO RECUR. REVIEW OF COMPLAINTS FOUND NO SIGNIFICANT TRENDS. THE ROOT CAUSE OF THE X-CONNECTOR INNER SCREW THREADS BECOMING TORN CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE NOTED TORN THREADS IS MOST LIKELY INDICATIVE OF AN INADVERTENT CROSS THREADING HAVING OCCURRED DURING SCREW TIGHTENING. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TRENDS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONCE THE MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR INNER SCREWS WERE ON POLYAXIAL SCREWS AND THE CROSS CONNECTOR WAS PLACED ACCORDINGLY, THE SURGEON STARTED THE PROCESS OF PLACING MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR OUTER NUTS TO BE ABLE TO LOCK THE PLATE. HE FELT THAT THE OUTER NUT WAS NOT GRABBING ONTO THE SCREW AND LATER DISCOVERED THAT THE THREADS FROM THE INNER SCREW WERE NO LONGER THERE. REPORTS IT WAS ALMOST LIKE THEY SHREDDED. THE DIFFICULTY OCCURRED A COUPLE OF TIMES AND BOTH INNER SCREWS WERE REPLACED INTRA-OPERATIVELY WITH NEW ONES. THE CONCOMITANT DEVICE OUTER NUTS WERE REPLACED AS WELL. BOTH WERE TIGHTENED WITH THE PROPER TORQUE AND THE REST OF THE CASE WAS UNEVENTFUL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SIGNIFICANT DELAY. SEE MFG MEDWATCH REPORT NO. 1526439-2014-11384 FOR THE SECOND MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR INNER SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150191 MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR INNER SCREW APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE BDHD2SW

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR MOUNTAINEER OUTER NUT, 188341100 X 2| MOUNTAINEER POLY SCREW, CAT# UNK