BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 36MM

    MDR report key: 6785033 · Received August 10, 2017

    Report

    Report Number
    1719045-2017-10755
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    July 18, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID (B)(6). DATE OF EVENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE HTY, JDW, JDN, HSB. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 ON (B)(6) 2016, A PATIENT WAS IMPLANTED WITH A SHORT TROCHANTERIC FIXATION NAIL (TFN) DUE TO A PROXIMAL FEMUR FRACTURE. ON AN UNKNOWN DATE IN (B)(6) 2017, THE PATIENT EXPERIENCED A FALL AND HAD A FEMUR FRACTURE AT THE SITE OF THE LOCKING SCREW. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 TO REPLACE THE SHORT TFN WITH A LONG TFN. THE SHORT NAIL, HELICAL BLADE, AND LOCKING SCREW WERE REMOVED INTACT AND REPLACED WITH A LONG NAIL, HELICAL BLADE, AND TWO DISTAL LOCKING SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND THE PATIENT OUTCOME WAS REPORTED AS EXCELLENT. THIS REPORT IS FOR ONE (1) 4.9 MM TI LOCKING BOLT 36 MM. THIS IS REPORT 3 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564507 4.9MM TI LOCKING BOLT 36MM NAIL,FIXATION,BONE JDS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention