TFN-ADVANCE 04.037.028SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982095862), received between Apr 18, 2018 and Dec 2, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Break; Break

  IT WAS REPORTED A TFNA NAIL BROKE INTRAOPERATIVELY ON AN UNKNOWN DATE. BROKEN HARDWARE WAS REMOVED AND THE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 23694927 ↗
• InjuryJul 29, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. HOW LONG HAS THE IMPLANT BEEN IN THE PATIENT? - 4 MONTHS. B. WHAT WAS THE REASON FOR REMOVAL/ REVISION SURGERY? - NAIL BROKE AT THE APERTURE OF THE PROXIMAL LAG SCREW. C. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - HIP PAIN. D. WAS THERE ANY ALLEGATION AGAINST THE TFNA SCREW? - NO.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22641716 ↗
• InjuryAug 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL BROKE IN THE PATIENT. THE BREAK WAS IN THE HELICAL BLADE HOLE IN THE NAIL. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM/ 125 DEG TI CANN TFNA 380MM/ RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10376384 ↗
• InjuryMay 20, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT WAS READMITTED TO THE HOSPITAL WITH HARDWARE FAILURE AND LOSS OF REDUCTION. INITIALLY, THE PATIENT HAD A TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) IMPLANTATION ON (B)(6) 2019 TO TREAT A CLOSED INTER SUBTROCHANTERIC FRACTURE. PATIENT HAD BEEN ENCOURAGED TO BEAR WEIGHT AS TOLERABLE. FOLLOW-UPS WERE DONE WEEKLY UNTIL THE INCISION HEALED. REVISION SURGERY OCCURRED ON (B)(6) 2019. PATIENT WAS REVISED TO A NEW 380MM, 130 DEGREE, 12MM TFNA AND A SUPPLEMENTARY PLATE TO HOLD AND ASSIST REDUCTION. PATIENT IS DOING WELL AND IS CURRENTLY WEIGHT-BEARING AS TOLERATED. THE FRACTURE IS NOT YET HEALED. CONCOMITANT DEVICES: HELICAL BLADE (PART: 04.038.390S, LOT: H679295, QUANTITY:1), 5.0MM TI LOCKING SCREW 56MM (PART: 04.005.546, LOT: UNKNOWN, QUANTITY: 1), 5.0MM TI LOCKING SCREW 70MM (PART: 04.005.560, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 10MM/125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8623997 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL FEMUR FRACTURE USING A TROCHANTERIC FIXATION NAIL - ADVANCE (TFNA) ON (B)(6) 2017. POSTOPERATIVELY, A NON-UNION WAS IDENTIFIED ON A ROUTINE FOLLOW-UP X-RAY. PATIENT WAS ASYMPTOMATIC (NO COMPLAINTS OF PAIN OR DISCOMFORT). THE PATIENT DID NOT HEAL DUE TO LATERAL CORTEX PORTION OF THE FEMUR BONE WAS MISSING BECAUSE OF THE COMPLEX FRACTURE PATTERN. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 AND RECEIVED A RIGHT TOTAL HIP REPLACEMENT. ALL THE REMOVED IMPLANTS WERE INTACT. THERE WERE NO ISSUES DURING THE REVISION AND NO SURGICAL TIME DELAY. THE PATIENT STATUS WAS STABLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7440669 ↗

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-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-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-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