TFN-ADVANCE 04.037.129SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982096432), received between Sep 11, 2018 and Dec 21, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2023Break; Break

  THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18374601 ↗
• InjuryJan 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2019 DUE TO A BROKEN TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) NAIL. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TFNA ON AN UNKNOWN DATE TO TREAT A HIP FRACTURE. POSTOPERATIVELY, THE PATIENT CAME INTO THE EMERGENCY ROOM WITH HIP PAIN. THE TFNA IMPLANTS WERE REMOVED AND THE PATIENT WAS IMPLANTED WITH TFN IMPLANTS. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR AN 11 MM/ 125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9554188 ↗
• InjuryJun 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF TITANIUM PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO BROKEN NAIL AND WAS REVISED TO SMITH AND NEPHEW INTERTAN NAIL. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), TFNA FENESTRATED SCREW 105MM - STERILE (PART# 04.038.205S, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8700833 ↗
• MalfunctionSep 11, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE SURGEON EXPERIENCED DIFFICULTY WHEN TRYING TO DISASSEMBLE THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HANDLE FROM THE END OF THE NAIL AFTER THE NAIL HAD BEEN IMPLANTED. THEY WERE USING THE STANDARD HANDLE IN THIS CASE AND THEY HAD A DIFFICULT TIME TRYING TO UNSCREW THE CONNECTING SCREW THAT HOLDS THE NAIL AND HANDLE TOGETHER DURING INSERTION, PROXIMAL TARGETING, ETC. IT SOUNDS LIKE THERE WAS QUITE A BIT OF SOFT TISSUE PUSHING AGAINST THE MEDIAL SIDE OF THE HANDLE WHICH IN TURN APPLIES BENDING/TWISTING FORCE ON THE CONNECTING SCREW AND NAIL THREADS CAUSING THEM TO BIND EXCESSIVELY. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS NOT PROVIDED. THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7866989 ↗

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