TFN-ADVANCE 04.037.915SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982097774), received between Jul 22, 2022 and Oct 10, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY OPERATED ON FOR A FEMORAL LENGTHENING OSTEOTOMY ON A NAIL IN THE CASE OF RIGHT CONSTITUTIONAL SHORTENING AGGRAVATED BY A LEG FRACTURE RESULTING IN ASSOCIATED LOSS OF HEIGHT. ON THE LEFT, A SUBTROCHANTERIC OSTEOTOMY OF THE FEMUR WAS PERFORMED IN ORDER TO GAIN FURTHER INEQUALITY ON (B)(6) 2022. UNFORTUNATELY, THE PATIENT SUFFERED AN EXCEPTIONAL COMPLICATION WITH THE LOCKING NAIL USED. THIS INVOLVED A SMALL NAIL THAT FRACTURED AT THE LOCKING SCREW HOLE. THIS COMPLICATION OCCURRED WHEN THE PATIENT WAS NOT APPLYING PRESSURE. THE PATIENT WAS VERY RIGOROUS AND DID NOT MAKE ANY ABNORMAL OR UNCONTROLLED GESTURES. THE PAIN APPEARED ON (B)(6) 2023 IN THE MORNING WHEN GOT UP WITHOUT MAKING ANY PARTICULAR EFFORT OR PRESSING DOWN. THIS NAIL RUPTURE LED TO COMPLICATIONS AND DELAYED CONSOLIDATION, JUSTIFYING DECORTICATION AND THE INSERTION OF A NEUTRALISATION PLATE WITH RESECTION OF THE ANTERIOR HYPERTROPHIC BONE CALLUS. THIS REPORT INVOLVES ONE (1) 9MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17904671 ↗
• InjuryJul 22, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY FOR TROCHANTERIC FRACTURE OF THE FEMUR. AFTER SURGERY, ON (B)(6) 2022, IT WAS FOUND THAT THE NAIL WAS BROKEN AT THE DISTAL END WHERE A LOCKING SCREW WAS INSERTED, AND THAT FRACTURE OCCURRED AS WELL. ON (B)(6) 2022, A REVISION SURGERY TO REPLACE THE NAIL WITH A LONGER ONE WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 15086338 ↗

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