TFN-ADVANCE 04.037.457SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982097613), received between Apr 27, 2018 and May 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023 THE SURGEON REPORTED TO SALES REP THAT HE HAD A PATIENT REPORT TO CLINIC WITH PAIN IN THE HIP REGION. THE PATIENT HAD A TFNA IMPLANTED FOR A HIP FRACTURE ON (B(6) 2023. UPON TAKING A NEW X-RAY, SURGEON SAW THAT THE HELICAL BLADE HAD ESCAPED THE NAIL LATERALLY CAUSING THE FEMORAL NECK TO COLLAPSE, REQUIRING A REVISION SURGERY. UPON REMOVING THE NAIL, WE FOUND THAT THE INTERNAL LOCKING MECHANISM WAS BROKEN. SURGEON PERFORMED THE REVISION SURGERY SUCCESSFULLY IMPLANTING ANOTHER TFNA NAIL AND HELICAL BLADE. SURGEON HAD REQUESTED THAT THE NAIL BE INVESTIGATED AND WOULD LIKE A REPORT BACK OF ANY FINDINGS. THIS REPORT IS FOR ONE (1) 14/130 DEG TI CANN TFNA 360/LEFT-STERILE THIS IS REPORT 1 OF 3 FOR COMPLAINT ON (B)(4).

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 16965404 ↗
• InjuryApr 27, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE 9MM 125 DEGREE CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LONG NAIL FOR PROXIMAL FEMORAL SUBTROCHANTERIC FRACTURES ON (B)(6) 2016. ON UNKNOWN DATE, IT WAS DETERMINED THAT THE NAIL HAD BROKEN AROUND THE BUMP-CUT AREA OF THE BLADE INSERTION HOLE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE THE NAIL WAS EXCHANGED FOR A TFNA LONG NAIL. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED SUDDEN PAIN IN THE FRACTURE AREA AROUND APRIL 2, 2018. X-RAYS REVEALED THE NAIL HAD AGAIN BROKEN AROUND THE BUMP-CUT AREA OF THE BLADE INSERTION HOLE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE NAIL WAS REMOVED. PATIENT WAS REVISED TO A BIPOLAR HIP ARTHROPLASTY (BHA) WITH NON-SYNTHES DEVICES. PROCEDURE WAS COMPLETED WITH A DELAY OF APPROXIMATELY 90 MINUTES. PATIENT REPORTED AS STABLE SINCE THE SECOND REVISION. SURGEON STATED THE CAUSE OF THE NAIL BREAKAGE FOR BOTH NAILS MAY HAVE BEEN METAL FATIGUE DUE TO PSEUDARTHROSIS, AS WELL AS THE PATIENT¿S BONE QUALITY. THE PATIENT¿S DAILY ACTIVITY, INCLUDING REHABILITATION FOR THE FIRST REVISION MAY HAVE ALSO PL

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7469979 ↗

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-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-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