BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE

    MDR report key: 5630695 · Received May 4, 2016

    Report

    Report Number
    1719045-2016-10369
    Event Type
    Injury
    Date Received
    May 4, 2016
    Report Date
    April 7, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT HAS BEEN REPORTEDLY DISCARDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (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: 20-JUL-2015. EXPIRATION DATE: 30-JUN-2025. LOT WAS RELEASE TO THE WAREHOUSE ON 20-JUL-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. 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.

    Additional Manufacturer Narrative · 1

    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 PRESENTED WITH A COMMINUTED SUBTROCHANTERIC RIGHT FEMUR FRACTURE ON (B)(6) 2015 AND WAS IMPLANTED WITH A 12 MM X 420 MM X 130 DEG TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND A 110 MM TI TFNA SCREW. THE PATIENT COMPLAINED OF PAIN IN THEIR HIP AROUND (B)(6) 2016 AND A CT SCAN REVEALED THE TFNA NAIL HAD BROKEN AT THE LEVEL OF THE LAG SCREW. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 AND THE NAIL WAS EXTRACTED ALONG WITH THE LOCKING SCREWS AND LAG SCREW. A 1.7 MM CERCLAGE CABLE AROUND THE PROXIMAL END OF THE FEMUR WAS IMPLANTED AND THE BROKEN NAIL WAS REPLACED WITH A 14MM X 440MM X 130 DEG TI TFNA NAIL. CONCOMITANT DEVICES REPORTED: TFNA SCREW 110MM - STERILE (04.038.110S, LOT#7911492, QUANTITY 1). (UNKNOWN SCREW LAG, LOT#: UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286176 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9856592

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention