TFN-ADVANCE 04.037.027SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095855), received between Sep 6, 2018 and Mar 26, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT ON MARCH 4, 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH TFNA. THE SURGEON TRIED TO INSERT THE END CAP AFTER NAIL INSERTION. NO MATTER HOW MANY TIMES THE SURGEON REINSERTED IT, IT NEVER COMPLETELY INSERTED INTO THE NAIL HOLE. IMAGING SHOWED THAT IT LOOKED LIKE IT WAS FLOATING ABOUT 1 MM. THE HOSPITAL HAD TWO END CAPS AND THE SURGEON TRIED THE OTHER ONE. HOWEVER, THE SAME EVENT OCCURRED. THEREFORE, THE SURGEON GUESSED THAT THE NAIL HAD A PROBLEM, AND THE PROCEDURE WAS COMPLETED AS IT WAS. THE LOCKING MECHANISM WAS RE-ENGAGED WITH A TORQUE SCREWDRIVER. THERE WAS NO STRANGE SOUND DURING INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21701376 ↗
• InjuryFeb 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A HIP NAIL SURGERY WITH THE TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) THE SET SCREW MALFUNCTIONED AND DID NOT LOCK THE UNKNOWN LAG SCREW INTO PLACE. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER NAIL. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE 10 MM/ 125 DEG TI CANN TFNA 360 MM/ LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9667882 ↗
• InjurySep 6, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2018, DUE TO A SUBTROCHANTERIC FRACTURE AND NON-UNION. THE PATIENT HAD A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) TITANIUM LAG SCREW AND A DISTAL LOCKING SCREW PREVIOUSLY IMPLANTED ON AN UNKNOWN DATE. A BROKEN TFNA LONG NAIL AND A BROKEN TITANIUM LAG SCREW WERE REPLACED WITH AN UNKNOWN BLADE PLATE. ALL HARDWARE WAS REMOVED SUCCESSFULLY WITHOUT ANY ISSUES. CONCOMITANT DEVICE REPORTED: DISTAL LOCKING SCREW (PART NUMBER 04.005.436, LOT UNKNOWN, QUANTITY OF 1) . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 7851917 ↗

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-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-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