TFN-ADVANCE 04.037.962SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982098221), received between Jan 22, 2018 and Jan 22, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WITH AN INITIALLY IMPLANTED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) UNDERWENT REMOVAL OF ONE (1) TFNA NAIL, ONE (1) LAG SCREW AND TWO (2) LOCKING BOLTS ON (B)(6) 2017 DUE TO NONUNION, BROKEN NAIL AND A SUSPECTED INFECTION. THE PATIENT WAS INITIALLY IMPLANTED WITH THE CONSTRUCT IN (B)(6) 2017. SUBSEQUENTLY, THE PATIENT REACHED OUT TO THE EMERGENCY AMBULATORY CARE ON (B)(6) 2017, WHERE AN UNKNOWN NUMBER OF X-RAYS TAKEN CONFIRMED THAT THE PATIENT HAD A HIP DEFORMITY AND THAT THE TFNA NAIL WAS BROKEN IN TWO PIECES. THE REMOVAL OF THIS TFNA CONSTRUCT WAS SCHEDULED FOR THE NEXT DAY, (B)(6) 2017. THE SURGEON BELIEVED THAT THERE WAS A POSSIBLE INFECTION AT THE SITE OF THE BROKEN TFNA ALONG WITH THE NONUNION AND DECIDED TO USE AN ANTIBIOTIC SPACER TO FIGHT OFF THIS SUSPECTED INFECTION. TISSUE CULTURES WERE ALSO TAKEN TO CONFIRM IF THERE WAS AN INFECTION AT THE SITE, THE RESULTS FOR THE CULTURES WERE NEGATIVE. THE SURGEON PLANS TO REVISE THE PATIENT TO A BLADE PLATE IN ORDER TO FIX THE FRACTURE. THE REMOVAL OF TFNA WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. NO ADDITIONAL INTERVENTIONS WERE REQUIRED TO COMPLETE THE SURGERY. THIS COMPLAIN

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7210352 ↗

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-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