BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE L80 TAN

    MDR report key: 6723437 · Received July 18, 2017

    Report

    Report Number
    3003506883-2017-10135
    Event Type
    Injury
    Date Received
    July 18, 2017
    Report Date
    June 20, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES: THERAPY DATES: (B)(6) 2017. 1X 04.037.012S / H113742 (TFNA FEM NAIL Ø10 125° L170 TIMO15), 1X 04.038.000S / L210389 (TFNA END CAP EXTENS. 0 TAN), 1X 04.005.526S / 9929080 (LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.280S LOT # H200713, RELEASE TO WAREHOUSE DATE: 28 OCTOBER 2016, EXPIRATION DATE: 01 OCTOBER 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 HELICAL BLADE 80MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: THE TFNA IMPLANTS IN QUESTION HAD BEEN IMPLANTED IN THE ORIF SURGERY FOR THE FEMUR TROCHANTERIC FRACTURE ON (B)(6) 2017. THE PRIMARY SURGERY WAS PERFORMED IN OTHER HOSPITAL ((B)(6) HOSPITAL, (B)(6)). ON (B)(6) 2017, THE REMOVAL SURGERY OF THE TFNA IMPLANTS IN QUESTION WAS PERFORMED IN THE REPORTED HOSPITAL. DURING THE REMOVAL SURGERY, IT WAS CONFIRMED WITH OUR SALES REP (ON-SITE) THAT THERE HAD BEEN THE CUT-OUT OF THE TFNA IMPLANTS IN QUESTION. IN ADDITION TO THE REMOVAL SURGERY, THA WAS ALSO PERFORMED. NO DELAY IN SURGERY WAS REPORTED IN THE PRIMARY SURGERY. PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICES: 1X 04.037.012S / H113742 (TFNA FEM NAIL Ø10 125° L170 TIMO15), 1X 04.038.000S / L210389 (TFNA END CAP EXTENS. 0 TAN), 1X 04.005.526S / 9929080 (LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502358 TFNA HELICAL BLADE L80 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA H200713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention