TFN-ADVANCE 04.037.113SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982096319), received between Apr 29, 2022 and Apr 29, 2022 — classified as 1 injury.

9 other recalls cover devices cleared under the same FDA submission (K131548, K160167); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION WITH THE TROCHANTERIC FIXATION NAIL- ADVANCED FOR THE FRACTURE OF THE DIAPHYSEAL FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SECONDARY FRACTURE HAD OCCURRED. A TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE, TFNA FEMORAL NAIL Ø11 125° L200 TIMO15, LOCKSCREW Ø5 L34 F/NAILS TAN- LIGHT GREEN, AND A TFNA END CAP EXTENSION 0 TAN WERE USED DURING THE PROCEDURE. ON (B)(6), 2022, THE REVISION SURGERY WAS PERFORMED TO REMOVE THE TROCHANTERIC FIXATION NAIL- ADVANCED AND FIX THE FRACTURE WITH A LONG GAMMA NAIL AND SCREWS. ACCORDING TO THE SURGEON, THIS EVENT WAS CAUSED BY A TECHNICAL ERROR DUE TO POOR IMPLANT INSERTION POINT, NOT PRODUCT MALFUNCTION. THE SURGEON THOUGHT THAT THE PATIENT HAD NOT FALLEN. THE SURGEON GUESSED THAT THE SECONDARY FRACTURE MAY BE A STRESS FRACTURE BECAUSE THE INSERTION POINT WAS POSTERIOR, AND THE TIP OF NAIL WAS HITTING THE ANTERIOR CORTICAL BONE. NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS REPORTED AS

  Patient problems: Bone Fracture(s)

  MAUDE report 14254558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, K160167. One submission often covers many models, so check the product and lot details in each record.

• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima