BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE

    MDR report key: 5894719 · Received August 22, 2016

    Report

    Report Number
    1719045-2016-10633
    Event Type
    Injury
    Date Received
    August 22, 2016
    Report Date
    August 8, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INITIALS NOT PROVIDED FOR REPORTING. (B)(4). DATE OF ORIGINAL IMPLANT:(B)(6) 2015. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BECAUSE IT WAS DISCARDED BY THE FACILITY. (B)(4): REVISION SURGERY WAS REQUIRED BECAUSE THE NAIL BROKE, AND THE PATIENT NEEDED FURTHER TREATMENT- THE PATIENT WAS CONVERTED TO A TOTAL HIP. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 20-JUL-2015, EXPIRATION DATE: 30-JUN-2025, PART #: 04.037.161S, LOT#: 9854971 (STERILE) - TFNA-11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. NO 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. (B)(4), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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 IN (B)(6) 2015 (EXACT DATE IS UNKNOWN) A PATIENT WAS IMPLANTED WITH A LONG TROCHANTERIC FIXATION NAIL-ADVANCE (TFNA) AS PROPHYLACTIC FIXATION FOR THE TUMOR IN THE PATIENT'S HIP. ON (B)(6) 2016, THE PATIENT RETURNED TO OPERATING ROOM TO UNDERGO REVISION SURGERY AS THE NAIL BROKE AT THE HELICAL BLADE/SCREW PROXIMAL HOLE AND ALSO TO GET DONE A TOTAL HIP. SURGEON USED EXTRACTION HOOK TO REMOVE THE DISTAL PORTION OF THE NAIL. ALL PIECES WERE SUCCESSFULLY REMOVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. TOTAL HIP WAS DONE DUE TO ARTHITIC HIP PAIN. THIS COMPLAINT INVOLVES 1 DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN BLADE (PART # UNKNOWN, LOT # UNKNOWN, QTY-1), DISTAL LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QTY-UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546399 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9854971

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention