BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 5344097 · Received January 5, 2016

    Report

    Report Number
    1719045-2016-10015
    Event Type
    Injury
    Date Received
    January 5, 2016
    Report Date
    December 15, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 03/13/2015. EXPIRATION DATE: 01/31/2024. PART #: 456.318S, LOT#: 7943725 (STERILE) - 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM - STERILE. LOT WAS RELEASED TO THE WAREHOUSE ON 03/13/2015. 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. 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 A PATIENT SUFFERED A LEFT FEMUR FRACTURE ON AN UNKNOWN DATE RESULTING IN THE PATIENT HAVING A TROCHANTERIC FIXATION NAIL (TFN) AND A TFN BLADE IMPLANTED. THE PATIENT REPORTEDLY RE-FRACTURED THE LEFT FEMUR BELOW THE ORIGINAL IMPLANT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015. ALL IMPLANTED DEVICES WERE SUCCESSFULLY EXPLANTED. THERE WERE NO FRAGMENTS GENERATED DURING THE SURGERY ALL DEVICES WERE INTACT AND REMOVED WITHOUT COMPLICATION. THE PATIENT'S STATUS WAS NOTED TO BE STABLE AT THE END OF SURGERY. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4582 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7943725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention