TFN-ADVANCE 04.037.225SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982097118), received between Jul 30, 2020 and Jul 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryJul 30, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY BY USING A COMPETITORS FEMORAL IMPLANT SYSTEM IN ORDER TO PREVENT BONE FRACTURES DUE TO THE BREAST CANCER BEING SPREAD TO THE FEMUR. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO REPLACE THE FEMORAL IMPLANTS DUE TO DEVICE BREAKAGE WITH SYNTHES TROCHANTERIC FIXATION NAIL ANTIROTATION (TFNA) LONG IMPLANTS. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF THE TFNA LONG IMPLANTS. THE PATIENT WAS REVISED TO ANOTHER SET OF IMPLANTS. THERE WAS A ONE (1) HOUR SURGICAL DELAY DUE TO EXTENDED TIME IN REMOVING THE BROKEN DEVICE. IT WAS FURTHER REPORTED THE PATIENT ALSO HAD A NON-UNION WHICH MAY HAVE CONTRIBUTED TO THE DEVICE BREAKAGE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Failure of Implant; Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10343455 ↗

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-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-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-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-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