BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TFNA

    MDR report key: 17237008 · Received June 30, 2023

    Report

    Report Number
    8030965-2023-08204
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 5, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: TFNA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ELBAZ E, ET AL. (2023), REDUCED CUTOUT FOR REVERSE OBLIQUE INTERTROCHANTERIC HIP FRACTURES TREATED WITH TROCHANTERIC FIXATION ADVANCED (TFN-A) NAIL COMPARED TO THE SHORT GAMMA-3 NAIL, SICOT-J 2023, 9, 16, HTTPS://DOI.ORG/10.1051/SICOTJ/2023013 (ISRAEL). THE PURPOSE OF THE PRESENT STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF THE UNKNOWN SYNTHES TROCHANTERIC FIXATION NAIL ADVANCED (TFN-A) IMPLANT WITH THE OUTCOMES OF THE COMPETITOR GAMMA 3-PROXIMAL FEMORAL NAIL (GPFN, MANUFACTURER: STRYKER) FOR THE TREATMENT OF REVERSE OBLIQUE FRACTURES. BETWEEN (B)(6) 2010 AND (B)(6) 2019, 203 PATIENTS WITH REVERSE OBLIQUE FRACTURES TREATED WITH EITHER TFN-A OR GPFN WERE INCLUDED IN THE STUDY. OF THESE PATIENTS, 66 WERE IMPLANTED WITH THE TFN-A (MEAN AGE OF 82.06 +/-11 YEARS, 49 FEMALES) FROM (B)(6) 2017 TO (B)(6) 2019. MEANWHILE THERE WERE 137 PATIENTS WHO WERE IMPLANTED WITH THE COMPETITOR DEVICE FROM (B)(6) 2010 TO (B)(6) 2017. ALL PATIENTS UNDERWENT CLOSED REDUCTION AND INTERNAL FIXATION WITHIN 48 HOURS OF PRESENTATION. POSTOPERATIVE MANAGEMENT INCLUDED EARLY MOBILIZATION, FULL-WEIGHT BEARING, AND PREVENTIVE PROPHYLACTIC TREATMENT FOR THROMBOEMBOLISM, WITH DAILY SUBCUTANEOUS INJECTION OF ENOXAPARIN SODIUM FOR 30 DAYS. PATIENTS WERE ROUTINELY EXAMINED AT 3 WEEKS, 6 WEEKS, 3 MONTHS, 6 MONTHS AND ONE YEAR POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 13 PATIENTS HAD UNSPECIFIED ORTHOPEDIC COMPLICATIONS. 1 PATIENT HAD MALUNION OR NONUNION. 4 PATIENTS UNDERWENT REVISION (REASON NOT SPECIFIED). THIS REPORT IS FOR AN UNK - CONSTRUCTS: TFNA. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854206 UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention