TFN-ADVANCE 04.037.254SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982097347), received between Apr 22, 2021 and Oct 5, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS:IT WAS REPORTED THAT ON (B)(6) 2023, THE TFNA BROKE AFTER CORRECT INSERTION AND INDICATION BUT ALSO AFTER A LONG TIME OF NONUNION OF THE FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - NAILS: TFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17875201 ↗
• InjuryJul 14, 2021Break; Break

  CONCOMITANT DEVICES: HELICAL BLADE (PART # 04.038.305, LOT # H696789, QUANTITY # 1) UNK - SCREWS: NAIL DISTAL LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12169467 ↗
• InjuryApr 22, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE SURGEON PUT A RIGHT TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL IN THE LEFT FEMUR. BEFORE NAIL INSERTION, THE SIZE, LENGTH, AND SIDE OF THE NAIL WAS CALLED OUT LOUD TO THE ROOM. NO ONE OBJECTED. THE NAIL WAS GIVEN TO THE NURSE, WHO OPENED THE NAIL AND GAVE IT TO SCRUB TECH. THE SCRUB TECH ATTACHED THE NAIL TO THE JIG AND GAVE IT TO THE DOCTOR WHO INSERTED THE NAIL. AFTER NAIL AND HELICAL BLADE WERE INSERTED, SURGEON WENT TO THE KNEE TO DO DISTAL INTERLOCKS. WHEN SURGEON TOOK THE FIRST X-RAY, IT WAS NOTICED THAT THE NAIL PERFORATED THE ANTERIOR CORTEX. SURGEON TOOK THE RIGHT TFNA NAIL OUT AND PUT THE LEFT TFNA NAIL IN, THEN PLATED THE DISTAL FEMUR WITH A VARIABLE ANGLE (VA) CONDYLAR PLATE. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 340MM/RIGHT-STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11709087 ↗

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-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-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