BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 85MM - STERILE

    MDR report key: 6535648 · Received May 1, 2017

    Report

    Report Number
    3003506883-2017-10069
    Event Type
    Injury
    Date Received
    May 1, 2017
    Report Date
    April 12, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 10MM/130 DEG TI CANN TFNA 380MM/RIGHT ¿ STERILE (PART #04.037.058S, LOT #H226204, QUANTITY 1) AND 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAIL-STER (PART #04.005.538S, LOT #H112570, QUANTITY 1). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.085S LOT # H154017; RELEASE TO WAREHOUSE DATE: 22 AUGUST 2016; EXPIRATION DATE: 31 JULY 2026; MANUFACTURING SITE: (B)(4). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA SCREW 85MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. HOWEVER BEFORE STERILIZATION, THE WORK ORDER WAS SPLIT TO INCLUDE A THERMAL RINSE PROCESS. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 INITIALLY UNDERWENT SURGERY ON (B)(6) 2017 FOR AN INTERTROCHANTERIC HIP FRACTURE, SIDE UNKNOWN, AND SUBSEQUENT PLACEMENT OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. THE PATIENT WAS IMPLANTED WITH ONE TFNA SCREW, ONE TITANIUM (TI) CANNULATED TFNA NAIL, AND ONE TI LOCKING SCREW. THERE WERE NO REPORTED ISSUES DURING THE INITIAL SURGERY. X-RAYS TAKEN ON (B)(6) 2017 REVEALED A NONUNION AND THAT THE TFNA SCREW HAD CUT OUT OF THE FEMORAL HEAD. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2017 FOR THE REMOVAL OF THE TFNA SCREW. IT WAS REPORTED THAT THE SCREW WAS EASILY REMOVED AND FOUND TO BE INTACT WITHOUT ANY PHYSICAL DAMAGES OBSERVED. IT WAS ALSO REPORTED THAT THE SURGEON OPTED NOT TO REPLACE THE TFNA SCREW AS THE PATIENT WAS VERY SICK AND NON-WEIGHT BEARING. THE TFNA NAIL AND LOCKING SCREW REMAIN IMPLANTED IN THE PATIENT. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS UNKNOWN. THIS COMPLAINT IS FOR ONE DEVICE CONCOMITANT MEDICAL PRODUCTS: 10MM/130 DEG TI CANN TFNA 380MM/RIGHT ¿ STERILE (PART #04.037.058S, LOT #H226204, QUANTITY 1) AND 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAIL-STER (PART #04.005.538S, LOT #H112570, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315796 TFNA SCREW 85MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA H154017

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention