BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE

    MDR report key: 6279014 · Received January 26, 2017

    Report

    Report Number
    1719045-2017-10057
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 6, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PART 04.037.956S, LOT H141868 (STERILE): MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JULY 12, 2016. EXPIRATION DATE: JUNE 30, 2026. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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

    PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY RECORDS REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE FOUR DEVICES WERE RETURNED STUCK TOGETHER. THE NAIL WAS FOUND TO HAVE DRILL MARKINGS ON THE OUTSIDE OF THE DEVICE NEXT TO THE PROXIMAL LOCKING HOLE, WHICH IS CONSISTENT WITH THE REPORT THAT THE BLADE MISSED THE NAIL. THE HELICAL BLADE IS CONFIRMED TO BE STUCK IN THE NAIL. THE CANNULATED CONNECTING SCREW WAS CONFIRMED TO BE STUCK TO THE NAIL AND IS RETAINED INSIDE THE INSERTION HANDLE. THERE APPEARS TO BE MATERIAL (METAL AND POSSIBLY BONE MATERIAL) INSIDE THE PROXIMAL LOCKING HOLE OF THE NAIL WHICH IS OBSTRUCTING THE HELICAL BLADE. THE METAL PIECE APPEARS TO BE THE LOCKING MECHANISM OF THE NAIL. IF THE LOCKING MECHANISM WAS NOT RETRACTED PRIOR TO INSERTION OF THE HELICAL BLADE, IT WOULD BE LIKELY TO CAUSE THE COMPLAINT CONDITION. USE OF THE RETURNED DEVICES IS OUTLINED IN THE TFN ADVANCED PROXIMAL FEMORAL NAILING SYSTEM SCREW ONLY - TECHNIQUE GUIDE. RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE CAUSE OF THE CONNECTING SCREW BECOMING STUCK TO THE NAIL IS UNABLE TO BE DEFINITIVELY DETERMINED. AN INVESTIGATION THAT WAS PERFORMED ON PREVIOUS COMPLAINTS HAS ALSO SHOWN THAT SOFT TISSUE PRESSURE CAN ALSO LEAD TO A JAMMING OF THE DEVICES. THEREFORE A NOTE WAS ADDED TO THE TFNA SURGICAL TECHNIQUE STATING: ¿IN CASE OF DIFFICULTIES TO REMOVE THE CONNECTING SCREW, PUSH THE INSERTION HANDLE TOWARDS MEDIAL OR LATERAL TO NEUTRALISE SOFT TISSUE PRESSURE.¿ IN ADDITION, BASED ON THE SERIES OF EVENTS IT IS POSSIBLE THAT ORGANIC MATERIAL REMAINED INSIDE THE NAIL AFTER THE INITIAL INSERTION AND WAS NOT CLEARED PRIOR TO RE-ATTACHMENT TO THE CONNECTING SCREW. 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

    IT IS REPORTED DURING A TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) PROCEDURE TO REPAIR A FRACTURE OF THE RIGHT FEMUR ON (B)(6) 2017, THE SURGEON IMPLANTED THE NAIL AND HELICAL BLADE. X-RAYS TAKEN AFTER INSERTION REVEALED THE BLADE MISSED THE NAIL AND WENT OFF TO THE SIDE OF IT. THE HYBRID INSERTION HANDLE AND CANNULATED CONNECTING SCREW WERE REASSEMBLED AND THE BLADE WAS REMOVED. SURGEON ATTEMPTED TO REINSERT THE HELICAL BLADE. THE BLADE REPORTEDLY BECAME STUCK HALF WAY INTO THE NAIL. SURGEON WAS UNABLE TO MOVE IT FORWARD OR BACKWARD. SURGEON THEN PULLED THE BLADE AND NAIL TOGETHER OUT OF THE FRACTURED FEMUR. THE BLADE, NAIL, INSERTION HANDLE, AND CONNECTING SCREW APPEAR TO BE COLD WELDED TOGETHER AND UNABLE TO BE SEPARATED. SURGEON THEN IMPLANTED A STANDARD TROCHANTERIC FEMORAL NAIL (TFN) AND BLADE WITH NO ISSUES. SECOND SET OF ADDITIONAL X-RAYS CONFIRM TFN BLADE DID INSERT INTO THE TFN NAIL AS EXPECTED. SURGERY WAS DELAYED APPROXIMATELY FOUR (4) HOURS DUE TO THIS ISSUE, BUT WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64662 9MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H141868

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention