BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 6335533 · Received February 16, 2017

    Report

    Report Number
    1719045-2017-10112
    Event Type
    Injury
    Date Received
    February 16, 2017
    Report Date
    January 23, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PART #04.037.142S LOT #H102639. RELEASE TO WAREHOUSE DATE: 13MAY2016. EXPIRATION DATE: 30APR2026. MANUFACTURED BY" MONUMENT. NO NONCONFORMANCES WERE GENERATED DURING PRODUCTION; REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AS AN X-RAY WAS NOT AVAILABLE TO VIEW THE PERIPROSTHETIC FRACTURE. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN AND NO CONTRIBUTING PRODUCT MALFUNCTION WAS IDENTIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW, DEVICE INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AS RECOMMENDED. THE RETURNED NAIL IS PART OF THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM AND REFERENCED IN THE TFNA TECHNIQUE GUIDE. THE NAIL WAS RECEIVED INTACT WITH THE NAIL EXTRACTOR STUCK IN THE PROXIMAL THREADS. THE CONDITION OF THE NAIL EXTRACTOR WILL BE INVESTIGATED UNDER (B)(4) AS THIS COMPLAINT ADDRESSES THE REMOVAL PROCEDURE DUE TO A PERIPROSTHETIC FRACTURE. WITNESS MARKS CONSISTENT WITH IMPLANT WERE OBSERVED ON THE SURFACES OF THE PROXIMAL AND DISTAL HOLES. THE BALANCE OF THE DEVICE SHOWS LIGHT SURFACE WEAR AND IS IN FUNCTIONAL CONDITION. RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AS RECOMMENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN AND NO CONTRIBUTING PRODUCT MALFUNCTION WAS IDENTIFIED. 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 UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO A LEFT PERIPROSTHETIC FRACTURE BELOW THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) DEVICES. THE ORIGINAL IMPLANT DATE WAS IN LATE 2016, POSSIBLY DECEMBER. THE FRACTURE WAS DISCOVERED VIA X-RAY ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE SURGEON REMOVED THE SHORT TFNA NAIL, LAG SCREW AND A DISTAL LOCKING SCREW AND REPLACED THEM WITH A LONG TFNA NAIL, HELICAL BLADE AND TWO (2) DISTAL LOCKING SCREWS. ALL OF THE HARDWARE WAS FOUND TO BE INTACT AND EASILY REMOVED. THERE WAS NO DELAY IN SURGERY AND THE PATIENT WAS REPORTED AS STABLE. THIS IS REPORT 1 OF 3 FOR COM-(B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118786 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H102639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention