TFN-ADVANCE 04.037.024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095824), received between Jan 16, 2019 and Feb 11, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL OF A BROKEN TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE ORIGINAL SURGERY WAS DONE IN JUNE AND POST-OP IMAGES WERE IN GOOD CONDITION. THIS IS THE SECOND FAILURE THAT THE SURGEON REPORTED ON (B)(6) 2022. THE OTHER FAILURE WAS A SUB-TROCHANTERIC NONUNION. THE NAIL WAS IN FOR OVER A YEAR BEFORE IT FAILED. THE PATIENT WAS REPORTED AS GOOD. THIS REPORT INVOLVES ONE (1) 10MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

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

  MAUDE report 13513916 ↗
• InjuryJan 16, 2019Break; Break

  01/16/2019. UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT THE CASE WAS COMPLETED ON (B)(6) 2017. THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) LAG SCREW AND UNKNOWN DISTAL LOCKING SCREW BROKE IN THE TFNA NAIL DURING AN UNKNOWN PROCEDURE. A PROPOSED REMOVAL PROCEDURE FOR A TOTAL HIP ARTHROPLASTY IS YET TO BE SCHEDULED. THERE WAS AN UNKNOWN SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVED THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8254067 ↗
• InjuryJan 16, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NONUNION AND A BROKEN TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) OF THE RIGHT HIP. ALL HARDWARE WAS REMOVED AND REVISED. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS STABLE. CONCOMITANT DEVICES: TFNA SCREW 80MM (PART: 04.038.080S, LOT: 9840313, QUANTITY: 1). 5.0MM LOCKING SCREW 42MM (PART: 04.005.532, LOT: UNKNOWN, QUANTITY: 1). 5.0MM LOCKING SCREW 38MM (PART: 04.005.528, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 10MM/125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8252555 ↗

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-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