BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 80MM STERILE

    MDR report key: 11202469 · Received January 20, 2021

    Report

    Report Number
    8030965-2021-00440
    Event Type
    Injury
    Date Received
    January 20, 2021
    Report Date
    December 23, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: PART 04.038.280S, LOT H201009: MANUFACTURING LOCATION: ELMIRA / MONUMENT. MANUFACTURING DATE: OCTOBER 05, 2016. EXPIRATION DATE: SEPTEMBER 01, 2026. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE 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 NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. 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)(7) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE RIGHT FEMORAL SHAFT FRACTURE WITH THE TFNA IMPLANTS AND 3NESPLON CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. SINCE 2019, THE PATIENT¿S RIGHT FEMUR FELT STRANGE. ON (B)(6) 2020, THE PATIENT COULD NOT WALK DUE TO PAIN. ON (B)(6) 2020 THE SURGEON CONFIRMED THAT THE NAIL HAD BROKEN AT THE NON-UNION PART. THE PATIENT WILL UNDERGO THE REVISION SURGERY ON (B)(6) 2021. IN THE REVISION, THE BROKEN NAIL WILL BE REMOVED, AND NEW IMPLANTS WILL BE SET. THE PATIENT HAS RHEUMATOID ARTHRITIS, DIABETES, OSTEOPOROSIS AND CHEST SPINAL CANAL STENOSIS. THE PATIENT ALSO HAS AN ALLERGY TO THE METAL. CONCOMITANT DEVICES REPORTED: 10MM/125 DEG TI CANN TFNA 300MM/RIGHT ¿ STERILE (PART NUMBER 04.037.020S, LOT H036461, QUANTITY 1). TFNA END CAP EXTENS. 0 TAN (PART NUMBER 04.038.000S, LOT L318262, QUANTITY 1). LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN (PART NUMBER 04.005.522S, LOT L047405, QUANTITY 1). LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN (PART NUMBER 04.005.522S, LOT L100374, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TFNA HELICAL BLADE 80MM STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98121 TFNA HELICAL BLADE 80MM STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH H201009

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN| LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN| TFNA END CAP EXTENS. 0 TAN| TFNA FEM NAIL Ø10 R 125° L300 TIMO15