BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE L70 TAN

    MDR report key: 10637088 · Received October 6, 2020

    Report

    Report Number
    8030965-2020-07754
    Event Type
    Injury
    Date Received
    October 6, 2020
    Report Date
    September 15, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819652408
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: THE COMPLAINT PRODUCT IS NOT AVAILABLE TO RETURN FOR INVESTIGATION. THE CLIENT RETAINING THE PRODUCT. DEVICE HISTORY LOT PART NUMBER: 04.038.270S, LOT NUMBER: 9982095, PART MANUFACTURING DATE: MARCH 25, 2016, MANUFACTURING SITE: ELMIRA, PART EXPIRATION DATE: MARCH 01, 2026, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9982095 OF TFNA HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON CONFORMANCES NOTED. 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(S) DETERMINED THE RAW MATERIAL LOT 9825565 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. 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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW /INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/ OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2020 DUE TO TROCHANTERIC FIXATION NAIL ANTI-ROTATION (TFNA) BLADE MIGRATION AND PATIENT REPORTS OF PAIN. THE PATIENT WAS REVISED TO A TOTAL HIP. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2019. THE PATIENT REPORTED PAIN ON (B)(6) 2020, AND VISITED THE HOSPITAL WHERE THE SURGEON CONFIRMED THAT THE BLADE HAD PENETRATED THE BONE HEAD. PATIENT AND REVISION PROCEDURE STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: TFNA FEM NAIL Ø9 125° L170 TIMO15 (PART # 04.037.912S, LOT # H876734, QUANTITY# 1), LOCKSCR 5 L30 F/NAILS TAN LIGHT GREEN (PART # 04.005.520S, LOT # 3L38566, QUANTITY # 1), TFNA END CAP EXTENS. 0 TAN (PART # 04.038.000S, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100715 TFNA HELICAL BLADE L70 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 9982095 07611819652408

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention LOCKSCR 5 L30 F/NAILS TAN LIGHT GREEN| TFNA END CAP EXTENS. 0 TAN| TFNA FEM NAIL Ø9 125° L170 TIMO15