TFN-ADVANCE 04.037.262SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982097422), received between Oct 9, 2018 and Sep 3, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAIN HAD A BROKEN HIP PIN AFTER PATIENT'S 90-DAY CHECK UP AFTER SURGERY. PATIENT INITIALLY BROKE THEIR HIP ON (B)(6) 2024 AND WENT TO HOSPITAL WHERE PATIENT UNDERWENT THE FIRST SURGERY WITH IMPLANTS INSERTED. SOMETIME BETWEEN (B)(6) 2025, AND (B)(6) 2025, PATIENT EXPERIENCE AN INTENSE PAIN IN THEIR HIP. PATIENT WENT BACK TO ER AND X-RAY SHOWED THAT ONE OF THE PINS ON THE HIP IMPLANT WAS BROKEN. REVISION SURGERY WAS DONE ON (B)(6) 2025, TO REPLACE THE PIN. SOON AFTER THE SURGERY, THE PATIENT GOT A LOCAL INFECTION AND IS TAKING ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 22956359 ↗
• InjuryApr 19, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PROXIMAL PORTION OF THE TFNA NAIL WAS BROKEN. THE IMPLANTS HAD BEEN IMPLANTED ABOUT THREE MONTHS AGO. THE TFNA IMPLANTS WERE EXTRACTED, AND THE RIA 2 WAS USED TO GATHER CULTURES. THE TFNA WAS REPLACED WITH A 10X420 RIGHT TFN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR

  Patient problems: Failure of Implant

  MAUDE report 16768126 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 PATIENT UNDERWENT A HARDWARE REMOVAL AND TOTAL HIP SURGERY DUE TO NON-UNION. THE PATIENT HAD A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DONE IN (B)(6) OF 2020. THE PATIENT VOICED TO SURGEON THAT HIS PREVIOUS SURGEON STATED IT WAS A HARDWARE FAILURE AND THAT IS WHY HE FAILED TO HEAL. THE SURGEON DOING SURGERY ON (B)(6) 2021 STATED IT WAS NOT A HARDWARE FAILURE AND IT WAS BECAUSE OF HIS BONE. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture; Unspecified Tissue Injury

  MAUDE report 11475291 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF NAIL, HELICAL BLADE, AND LOCKING SCREWS FOLLOWED BY A TOTAL HIP REPLACEMENT SURGERY DUE TO TERRIBLE ARTHRITIS. INITIALLY, THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) ON AN UNKNOWN DATE. THE HARDWARE REMOVAL AND TOTAL HIP REPLACEMENT SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED HELICAL BLADE 100MM (PART NUMBER 04.038.400, LOT H556431, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS (PART NUMBER 04.005.538, LOT UNKNOWN, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS (PART NUMBER 04.005.538, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 11139918 ↗
• InjuryAug 27, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HIP REVISION DUE TO TFNA BROKEN NAIL. THE PATIENT HAD AN ORIGINAL IMPLANT OF ONE (1) TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, ONE (1) TFNA FENESTRATED SCREW/LAG SCREW AND TWO (2) UNKNOWN 5.0 TITANIUM LOCKING SCREWS ON (B)(6) 2019 DUE TO HIP FRACTURE. THE PATIENT HAD NO HEALING. THE TFNA NAIL BROKE. THE (TFNA) FENESTRATED SCREW/LAG SCREW AND THE TWO UNKNOWN 5.0 TITANIUM LOCKING SCREWS WERE INTACT. IMPLANTS WERE REMOVED WITH NO PROBLEM. THE PATIENT REVISED TO A SMITH AND NEPHEW INTERTAN TROCH NAIL AFTER THE TFNA BROKEN HARDWARE WAS REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME TURNED OUT FINE. CONCOMITANT DEVICES REPORTED: TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED SCREW/LAG SCREW (PART#: 04.038.205, LOT#: H318498, QUANTITY 1), UNKNOWN LOCKING SCREWS (PART#: UNKNOWN; LOT#: UNKNOWN; QUANTITY 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8935829 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY OF THE HIP DUE TO IMPLANT FAILURE AND FAILURE TO HEAL. THE REASON FOR THE FAILURE TO HEAL IS UNKNOWN. THE FAILED IMPLANT INVOLVED TROCHANTERIC FEMORAL NAILING ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA- HELICAL BLADE, AND UNKNOWN LOCKING SCREWS WHICH WERE REMOVED AND REPLACED. THE SURGEON INSERTED A NEW TFNA NAIL AND TFNA-TITANIUM CANNULATED SCREW IN PLACE OF THE HELICAL BLADE. IT WAS THE SURGEON'S PREFERENCE TO REPLACE THE HELICAL BLADE WITH THE SCREW. ACCORDING TO THE SURGEON, THERE WERE NO OBVIOUS ERRORS IN THE ORIGINAL SURGERY OR IMPLANT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7947133 ↗

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-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-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