TFN-ADVANCE 04.037.264SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982097446), received between Nov 12, 2019 and Feb 3, 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.

• InjuryFeb 3, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS DISCOVERED THAT PATIENT SUFFERED NONUNION OF INTERTROCHANTERIC FRACTURE. ADDITIONALLY, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL WAS BROKEN AT THE LAG SCREW/NAIL INTERFACE. PATIENT WAS REVISED TO TOTAL HIP ARTHROPLASTY (THA). HARDWARE WAS REMOVED WITHOUT INCIDENT. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 440MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16298404 ↗
• InjuryNov 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A HARDWARE REMOVAL AND IMPLANTATION OF A FEMORAL RECON NAIL DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LONG NAIL. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH TFN-ADVANCED SYSTEM LONG NAIL FOR A COMMINUTED RIGHT SUBTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2019. THE PATIENT WAS IN PHYSICAL THERAPY AND DOING A ONE-LEGGED STANCE EXERCISE AND FELT PAIN. UPON A ROUTINE FOLLOW UP WITH THE SURGEON, IT WAS FOUND THAT THE TFN-ADVANCED SYSTEM LONG NAIL BROKE. REVISION SURGERY WAS DONE FOR THE NONUNION, THE TFN-ADVANCED SYSTEM LONG NAIL WAS REMOVED, AND THE PATIENT WAS IMPLANTED WITH A FEMORAL RECON NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICES: UNKNOWN HELICAL BLADE TFNA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 12 MM/130 DEG TI CANN TFNA 440 MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9311560 ↗

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-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-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