BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 6071398 · Received November 1, 2016

    Report

    Report Number
    1719045-2016-10803
    Event Type
    Injury
    Date Received
    November 1, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER NUMBER: UDI: (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW FOR PART # 04.037.242S, LOT # 9841350 MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 2015-06-30, EXPIRATION DATE: 2025-05-31. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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. 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 WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON AN UNKNOWN DATE FOR A DISTAL FEMUR FRACTURE USING THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, ONE HELICAL BLADE AND ONE DISTAL LOCKING SCREW. PATIENT HAD A FALL AND BROKE HIS DISTAL FEMUR BONE AGAIN. PATIENT HAD REVISION SURGERY ON (B)(6) 2016 AND IT WAS REPORTED THAT THE HELICAL BLADE CUT OUT THRU THE RIGHT FEMORAL HEAD BONE AND THE DISTAL LOCKING SCREW WAS BROKEN IN HALF. PATIENT ALSO PRESENTED WITH A MAL-UNION FROM THE ORIGINAL SURGERY. SURGEON EXPLANTED THE NAIL, BLADE AND LOCKING SCREW AND REVISED THE PATIENT USING THE 4.5MM VA PLATE AND SCREW SYSTEM. PATIENT IS REPORTED IN STABLE CONDITION AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719758 12MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9841350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention