BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAIL HEAD ELEM: TFNA

    MDR report key: 21792883 · Received April 7, 2025

    Report

    Report Number
    8030965-2025-03311
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 4, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GONZALO GB, JUAN C, MACARENA L, LIONEL L, CARLOS S, DANILO T, GUIDO C, JORGE B. TROCHANTERIC HIP FRACTURES WITH SUBTROCHANTERIC EXTENSION. DOES THE CEPHALOMEDULLARY NAIL LENGTH MATTER? EUR J ORTHOP SURG TRAUMATOL. 2025 MAR 4;35(1):91. DOI: 10.1007/S00590-025-04222-7. PMID: 40038205. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE FUNCTIONAL OUTCOMES BEFORE AND 1 YEAR AFTER SURGICAL FIXATION OF TROCHANTERIC FRACTURES WITH SUBTROCHANTERIC EXTENSION, REOPERATION RATE, 1-YEAR MORTALITY RATE, SURGICAL TIME, FRACTURE REDUCTION QUALITY, AND TIP¿APEX DISTANCE (TAD) IN PATIENTS WHO HAD EITHER STANDARD CEPHALOMEDULLARY OR LONG NAILS. BETWEEN JANUARY 1, 2015, AND DECEMBER 31, 2021, A TOTAL OF 1533 PER-INTERTROCHANTERIC FRACTURES WERE SURGICALLY TREATED, OF WHICH 178 (16 MALES AND 162 FEMALES WITH MEAN AGE AGED > 65 YEARS) (11.6%) HAD SUBTROCHANTERIC EXTENSION. OF THE 178 FRACTURES INCLUDED, 131 (73.60%) WERE TREATED WITH STANDARD NAILS (FIG. 2) AND 47 (26.40%) WITH LONG NAILS. ALL PATIENTS AGED > 65 YEARS WHO UNDERWENT HIP SURGERY BECAUSE OF TROCHANTERIC FRAGILITY FRACTURE WITH SUBTROCHANTERIC EXTENSION > 2 CM FROM THE LESSER TROCHANTER (AO CLASSIFICATION 31A2.3/31A3) ALL FRACTURES WERE TREATED WITH THE TFNA (TROCHANTERIC FIXATION NAIL ADVANCED¿DEPUY SYNTHES). THE STANDARD NAIL USED IN GROUP 1 HAD DIAMETERS OF 10, 11, AND 12 MM, WITH A NECK¿SHAFT ANGLE OF 125° OR 130°. IN GROUP 2, THE LONG IMPLANT HAD DIAMETERS OF 9 AND 10 MM AND THE SAME NECK¿SHAFT ANGLE. ALL NAILS WERE DISTALLY LOCKED IN A STATIC POSITION, WITH ONE 5-MM SCREW IN GROUP 1 AND TWO 5-MM SCREWS IN GROUP 2. WITH MEAN A 1-YEAR FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SYNTHES TROCHANTERIC FIXATION NAIL ADVANCED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TFNA (10 QTY): 1 PATIENT CUTTING OUT. NO TREATMENT INDICATED. 2 PATIENTS CUTTING-THROUGH. NO TREATMENT INDICATED. 1 PATIENT HAD NON-UNION. NO TREATMENT INDICATED. 3 PATIENTS HAD INFECTION. NO TREATMENT INDICATED. 1 PATIENT HAD PERI-IMPLANT FRACTURE. NO TREATMENT INDICATED. 2 PATIENTS HAD IMPLANT BREAKAGE. NO TREATMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582607 UNK - NAIL HEAD ELEM: TFNA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown