BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS

    MDR report key: 7422107 · Received April 11, 2018

    Report

    Report Number
    2939274-2018-51582
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 19, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    PMA / PMN Number
    K172157
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL 510K: K000089. PATIENT CODE (B)(4) USED FOR: A HARDWARE REMOVAL PROCEDURE ON MARCH 13, 2018 DUE TO A NONUNION IN THE RIGHT FEMUR, CAUSED BY BROKEN HARDWARE (2 SCREWS). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MED-WATCH, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE, AND A FOLLOW-UP MED-WATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2018 DUE TO A NONUNION IN THE RIGHT FEMUR, CAUSED BY BROKEN HARDWARE (2 SCREWS). THE PATIENT WAS ORIGINALLY IMPLANTED WITH A NAIL AND THREE LOCKING SCREWS ON (B)(6) 2017. HOWEVER, IT WAS LATER DISCOVERED THAT TWO OF THE IMPLANTED SCREWS HAD BROKEN. DURING THE (B)(6) 2018 PROCEDURE WHOLE OF THE IMPLANTED HARDWARE WAS REMOVED. ONE OF THE SCREWS WAS REMOVED EASILY, WHILE THE REMAINING TWO (THE BROKEN SCREWS) AND THE PLATE HAD TO BE REMOVED THROUGH A SEPARATE MEDIAL INCISION. NO INFORMATION IS AVAILABLE OR CAN BE RECEIVED ABOUT THE INCISION OR THE RESULTS OF THE PROCEDURE. IT IS UNKNOWN WHICH TWO OF THE THREE SCREWS WERE THE BROKEN ONES. THIS REPORT INVOLVES 1 DEVICE. REPORTED CONCOMITANT DEVICE NAIL 11MM 400MM FEMORAL RETRO/ANTEGRADE (PART NUMBER: 04.013.560S, LOT NUMBER: H321515, QUANTITY: 1) THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265119 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1