BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6036493 · Received October 18, 2016

    Report

    Report Number
    1719045-2016-10761
    Event Type
    Injury
    Date Received
    October 18, 2016
    Report Date
    September 29, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) USED TO REPORT THAT THE PATIENT DEVELOPED A FRACTURE BELOW THE IMPLANT, WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE CONSTRUCT AND REVISE TO A LONG TFNA NAIL CONSTRUCT. DEVICE HISTORY RECORD REVIEW FOR PART NUMBER 04.037.242S AND LOT NUMBER H132201 (STERILE) REVEALED THAT NO NON CONFORMANCE REPORTS (NCRS) 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) - SHORT, A HELICAL BLADE, AND A LOCKING SCREW ON (B)(6) 2016 TO REPAIR A RIGHT FEMUR FRACTURE. AFTER THE SURGERY, ON AN UNKNOWN DATE, THE PATIENT SUFFERED ANOTHER FRACTURE BELOW THE IMPLANTED NAIL. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE TFNA - SHORT WAS REMOVED AND THE PATIENT WAS REVISED TO A TFNA LONG AND 2 DISTAL SCREWS AND A HELICAL BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688625 12MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H132201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention