BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 46MM

    MDR report key: 7007045 · Received November 7, 2017

    Report

    Report Number
    1719045-2017-11156
    Event Type
    Injury
    Date Received
    November 7, 2017
    Report Date
    October 14, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTY
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: JDW, JDS, JDN, HSB. (B)(4). DATE OF IMPLANT IS APPROXIMATELY THREE WEEKS PRIOR TO REVISION ON (B)(6) 2017. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERAPY DATE IS APPROXIMATELY THREE WEEKS PRIOR TO REVISION ON (B)(6) 2017. (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 A PATIENT WAS IMPLANTED WITH A TFN (TROCHANTERIC FIXATION NAIL) SYSTEM CONSISTING OF A TROCHANTERIC FIXATION NAIL, HELICAL BLADE AND 4.9MM LOCKING BOLT TO TREAT A SUB TROCHANTERIC FRACTURE. REPORTEDLY, PATIENT WAS NON-COMPLIANT AND WEIGHT BEARING. PATIENT EXPRESSED THAT HARDWARE HAD BROKEN ON AN UNKNOWN DATE. APPROXIMATELY THREE WEEKS STATUS POST, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 TO REMOVE THE BROKEN LOCKING BOLT. IT WAS NOTED THAT THE LOCKING BOLT BROKE IN HALF WITHOUT GENERATING ANY FRAGMENTS. THE LOCKING BOLT WAS EASILY REMOVED. ONE HALF WAS REMOVED LATERALLY AND THE OTHER HALF WAS REMOVED MEDIALLY. THERE WERE NO ISSUES WITH THE NAIL OR HELICAL BLADE AND BOTH DEVICES REMAINED INTACT IN THE PATIENT. PATIENT WAS REVISED TO ONE (1) 5.0MM LOCKING SCREW, 46 MM AND TWO (2) 5.0MM LOCKING SCREWS 48MM. THERE WAS NO SURGICAL DELAY AND ROUTINE X-RAYS WERE TAKEN INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: TROCHANTERIC FIXATION NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1) HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS REPORT IS FOR ONE (1) 4.9MM TI LOCKING BOLT 46MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786756 4.9MM TI LOCKING BOLT 46MM PIN,FIXATION,SMOOTH HTY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention