TFN-ADVANCE 04.037.045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982096012), received between Sep 13, 2020 and Oct 28, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A LEFT NAIL WAS OPENED BY THE NURSE FOR A RIGHT TROCHANTERIC FRACTURE AND WAS IMPLANTED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402797 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT EXPERIENCED A POSTOPERATIVE BROKEN TFNA NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062661 ↗
• InjurySep 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , CONTROL CT IMAGES SHOWED A FINE NAIL FACTURE POSTOPERATIVELY. THE NAIL IS CURRENTLY STILL IMPLANTED, AND THE FRACTURE IS ALMOST HEALED. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20279484 ↗
• InjuryAug 19, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT 10MM INTERMEDIATE TFNA BROKE AT THE CENTER POINT OF DISTAL INTERLOCKING HOLE. NAIL APPEARED TO HAVE BEEN DAMAGED BY DRILL BIT DURING THE INITIAL CASE ON (B)(6) 2022. X-RAYS OF INITIAL CASE SHOWED DAMAGE TO THE NAIL INTRAOPERATIVELY. NAIL WAS TAKEN OUT AND REPLACED WITH LONG TFNA (B)(6) 2022. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 10/130 DEG TI CANN TFNA 235/LEFT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15259422 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH THE NAIL, END CAP, BLADE, LOCKING SCREW AND CEMENT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. LATER, ON (B)(6) 2022 IT WAS CONFIRMED THAT PENETRATION OF THE IMPLANT OCCURRED DUE TO OSTEONECROSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 14828391 ↗
• MalfunctionJun 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A TFNA NAIL WOULD NOT CONNECT TO THE CONNECTING SCREW (03.037.010). THE CUSTOMER OPENED ANOTHER NAIL AND IT CONNECTED FINE. CONCOMITANT DEVICE REPORTED: CANNULATED CONNECTING SCREW(PART:03.037.010 LOT# UNKNOWN; QUANTITY: 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE 10/130 DEG TI CANN TFNA 235/LEFT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801555 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PROXIMAL FEMUR FRACTURE AND A DISTAL FEMUR FRACTURE OCCUR. X-RAYS SHOWED THE BONE HAD SCREW TRACTS IN PLACES THAT THE SCREWS WERE NOT CURRENTLY LOCATED. THE SURGEON THOUGHT THE DISTAL PORTION OF THE FEMUR HAD PREVIOUSLY BEEN REVISED. THE PATIENT THEN HAD THE PROCEDURE TO REMOVE THE TFNA NAIL, AND A ZIMMER NAIL WAS PLACED. IT IS UNKNOWN IF THIS WAS EITHER THEIR THIRD OR FOURTH SURGERY.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12990300 ↗
• MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 WHILE DOING AN INTERMEDIATE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) THE TFNA SCREW BOUND UP IN THE TFNA NAIL DURING INSERTION AND COULDN'T BE ADVANCED ALL THE WAY. THE TFNA SCREW WAS REMOVED USING THE EXTRACTOR IN THE TFNA SET. THE NAIL WAS REMOVED AND A NEW NAIL AND SCREW WERE IMPLANTED. THE CASE WENT SMOOTHLY AFTER THE REMOVAL OF THE NAIL. A THREAD FROM THE SCREW WAS SEEN AND REMOVED. THE NAIL CAME OUT EASILY AS IT WAS STILL ATTACHED TO THE INSERTION HANDLE. THERE WAS A DELAY OF ABOUT FIVE (5) MINUTES TO REMOVE AND REINSERT THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - EXTRACTION INSTRUMENTS: TFNA/PFNA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214545 ↗
• InjuryNov 6, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT SURGERY WHERE CEPHALIC SCREW AND TFNA NAIL WERE IMPLANTED. FIVE (5) MONTHS LATER, THE PATIENT PRESENTED TO THE DOCTOR'S OFFICE WITH PAIN. AN X-RAY SHOWED THE SPLIT NAIL. ON (B)(6) 2020 REVISION SURGERY WAS PERFORMED TO EXTRACT THE TFNA NAIL DUE TO IMPLANT FAILURE AS THE NAIL SPLIT IN THE CEPHALIC PART. THE SURGEON REPOSITIONED A NEW TFNA NAIL AND LAG SCREW. IT WAS REPORTED THAT THE NAIL BROKE WITHIN THE PATIENT THREE (3) MONTHS AFTER PLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10803200 ↗
• MalfunctionSep 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS A SURGICAL DELAY OF THREE (3) TO FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10600529 ↗
• InjurySep 13, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TFNA FEM NAIL WAS BROKEN IN THE PROXIMAL SEGMENT ABOVE THE CEFALLOMEDULAR IMPLANT IN THE PATIENT. THERE WAS PATIENT CONSEQUENCE. THE IMPLANT WAS EXPLANTED ON (B)(6) 2020 AND A NEW IMPLANT WAS PLACED. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FEM NAIL Ø10 LE 130° L235 TIMO15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; No Code Available

  MAUDE report 10526257 ↗

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-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-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