TFN-ADVANCE 04.037.943SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982098030), received between Apr 1, 2024 and Feb 19, 2026 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Break

  VIA USER REPORT: IMPLANT FAILURE WITH FRACTURE OF TFNA.

  Patient problems: Insufficient Information

  MAUDE report 24393821 ↗
• MalfunctionJul 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT SUSTAINED A MOTORCYCLE ACCIDENT. HE HURT HIS RIGHT HIP. HE COULD NOT MOVE HIS RIGHT HIP DUE TO PAIN. DIAGNOSIS, CLOSED DISPLACE UNSTABLE INTERTROCHANTERIC FRACTURE OF RIGHT FEMUR ON (B)(6) 2025, SURGERY PERFORMED. MINI-OPEN REDUCTION INTERNAL FIXATION WITH TFNA RIGHT HIP. THE SURGERY WAS SUCCESSFUL. ON (B)(6) 2025, AMBULATION WITH WALKER WITH PARTIAL WEIGHT BARING RIGHT LEG. PATIENT HOSPITAL DISCHARGE POST-OPERATIVE FOLLOW-UP: AT 1 MONTH: POST-OPERATIVE FOR 4 WEEKS, HE IS DOING WELL WITH FULL WEIGHT-BEARING WALKING WITHOUT CRUTCHES. AT 2 MONTHS: POST-OPERATIVE FOR 2 MONTHS, HE IS DOING WELL WITH NO PAIN IN THE RIGHT HIP. HE CAN WALK NORMALLY SINCE AFTER THE OPERATION AND SOMETIMES USES A WALKER. ON (B)(6) 2025, AN ABNORMAL FILM WAS FOUND WHERE THE BLADE HEAD PENETRATED THE HIP JOINT. THE DOCTOR EXAMINED THE PATIENT, WHO COULD WALK NORMALLY, AND FOUND ONLY SLIGHT PAIN AROUND THE KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506607 ↗
• InjuryApr 1, 2024Break; Break

  IT WAS FURTHER REPORTED THE PATIENT HAD NON-UNION. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT SURGICAL DELAY.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19012295 ↗

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-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-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