BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 5812067 · Received July 21, 2016

    Report

    Report Number
    1719045-2016-10561
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 16, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. (B)(4). DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART 04.037.042S, LOT H022520 (STERILE): MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JANUARY 27, 2016. EXPIRATION DATE: JANUARY 31, 2026. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY FOR INTERTROCHANTERIC FEMORAL FRACTURE ON (B)(6) 2016, THE SURGEON PALPATED THE FRACTURED PART FROM THE INCISIONAL PART AND CONFIRMED THAT CALCAR OF THE FEMORAL TROCHANTER WAS REDUCED TO A POSITION WHERE THE FRACTURED BONE ATTACHED TO THE OTHER SITE OF THE BONE. ON (B)(6) 2016, IT WAS NOTED EXCESS SLIDING OF THE REPORTED TITANIUM TROCHANTERIC FIXATION NAIL ADVANCED (TFN-A) HELICAL BLADE WAS DETECTED. THE SURGEON INDICATED THAT THE FEMORAL HEAD MIGHT ROTATE AND THE ROTATING COULD HAVE LED TO THE EXCESS SLIDING FROM THE REDUCED POSITION. IN ADDITION, THE SURGEON COMMENTED THAT TFN-A BLADES WERE STABLE TO ROTATE AND ROTATING RIGHT AFTER INTERNAL FIXING OF THE HUMERAL HEAD WAS UNUSUAL; THEREFORE, THE SURGEON FELT THAT THE LOCKING STRUCTURE MAY NOT HAVE STAYED LOCKED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464628 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H022520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention