BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SNAP-ON OPEN PARALLEL CONNECTOR 5.5MM/5.5MM W/2 SCR

    MDR report key: 6066798 · Received October 31, 2016

    Report

    Report Number
    2530088-2016-10303
    Event Type
    Injury
    Date Received
    October 31, 2016
    Report Date
    October 17, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K111358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION: ALTHOUGH IT WAS STATED THAT THE COMPLAINT INVOLVES THREE PARTS, ONLY ONE WAS RETURNED AND HAD A KNOWN LOT NUMBER, THEREFORE ONLY THE RETURNED IMPLANT WAS INVESTIGATED. THE RETURNED SNAP-ON OPEN PARALLEL CONNECTOR (04.633.403, 6982707) IS PART OF THE MATRIX SPINE SYSTEM AND INCLUDED IN THE MATRIX SPINE SYSTEM ¿ DEGENERATIVE TECHNIQUE GUIDE. SNAP-ON OPEN PARALLEL CONNECTORS ARE ONE OF THE IMPLANT OPTIONS OFFERED AS PART OF THE MATRIX SYSTEM AND ARE USED TO CONNECT RODS WHEN BUILDING A SPINE CONSTRUCT. THE RETURNED CONNECTOR WAS RECEIVED WITH NOTICEABLE EVIDENCE OF IT BEING EXPLANTED AND THE EXPECTED DAMAGE WHICH CAN OCCUR, SUCH AS SCRATCHES AND SUPERFICIAL MARKS. THE COMPLAINT CONDITION COULD NOT BE REPLICATED BUT WILL BE DEEMED CONFIRMED BASED ON THE COMPLAINT DESCRIPTION. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION, DRAWING REVIEW, ROOT CAUSE ANALYSIS, AND RISK MANAGEMENT ASSESSMENT WERE PERFORMED. THE RETURNED SNAP-ON OPEN PARALLEL CONNECTOR (04.633.403, 6982707) WAS MANUFACTURED ON 11-FEB-2013 AND DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. DURING DHR REVIEW IT WAS NOTED THAT THE SUBJECT LOT (6982707) WAS RETURNED TO SUPPLIER FOR ROOT CAUSE ANALYSIS AND REPLACEMENT OF THE 04.633.400.3 COMPONENT FOR RETURN SHIPMENT TO SYNTHES. UPON INSPECTION IT WAS FOUND THAT THE T15 SET SCREWS PROPERLY MATED WITH A KNOWN WORKING T15 STARDRIVE SHAFT (03.614.019, 6725554) TIP AND THE SET SCREWS COULD BE EFFECTIVELY LOOSENED AND TIGHTENED. ALL OTHER NOTES IN THE DHR REVIEW DID NOT PERTAIN TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION. THERE WAS NO MENTION IN THE COMPLAINT CONDITION OF THE RETURNED CONNECTOR NOT PROPERLY CONNECTING DURING THE INITIAL PROCEDURE. IT IS POSSIBLE THAT THE CONNECTOR WAS NOT USED AS INTENDED NOR FOLLOWING SPECIFIC PROCEDURAL GUIDANCE PROVIDED IN THE RELEVANT MATRIX TECHNIQUE GUIDE(S). IF THE INITIAL SPINE CONSTRUCT WAS NOT ASSEMBLED APPROPRIATELY IN ORDER TO SUSTAIN THE EXPECTED FORCES EXPERIENCED UNDER NORMAL CIRCUMSTANCES AND/OR IF THE PATIENT WAS NOT COMPLIANT POST-SURGERY, IT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    PT YEAR OF BIRTH REPORTED AS 1936. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. DATE OF EXPLANT: UNKNOWN; REPORTED AS ONE WEEK AFTER IMPLANTATION. (B)(6). PART 04.633.403, LOT 6982707: RELEASE TO WAREHOUSE DATE: FEBRUARY 11, 2013. MANUFACTURED BY SYNTHES (B)(4). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IT WAS NOTED THAT ONE OF THE PILOT HOLES WAS UNDERSIZED MAKING IT SEEM LIKE ANOTHER DIMENSION WAS OUT OF SPECIFICATION. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT EXTENSION OF SPONDYLODESIS TO THE ILIUM DUE TO ADJACENT SACRUM FRACTURE WAS NEEDED. IN ORDER NOT TO OPEN UP THE ENTIRE EXISTING CONSTRUCT, THE SURGEON USED THREE SIDE TO SIDE CONNECTORS ON ONE SIDE. ONE WITH TWO SET-SCREWS AND TWO WITH JUST ONE SET-SCREW EACH. ON THE OTHER SIDE THE ROD WAS LONG ENOUGH TO ATTACH THE ILIUM CONNECTOR DIRECTLY TO THE ROD. ABOUT ONE WEEK AFTER SURGERY THE PATIENT HAD A ROUTINE X-RAY WHERE THE DETACHMENT OF ALL THREE (3) CONNECTORS WAS VISIBLE. THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE ADDITIONAL ROD AND THE CONNECTORS WERE REMOVED AND A LONGER ROD WAS USED TO BRIDGE AND FIX THE SACRUM FRACTURE. SO FAR THE PATIENT IS FINE NOW. CONCOMITANT MEDICAL PRODUCTS: ROD (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718129 TI SNAP-ON OPEN PARALLEL CONNECTOR 5.5MM/5.5MM W/2 SCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 6982707

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN ROD