TFN-ADVANCE 04.037.152SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982096609), received between Jun 4, 2021 and Apr 14, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Material Discolored; Material Deformation

  IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871253 ↗
• MalfunctionMar 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AN 11 X 320MM RIGHT 130 DEGREE TFNA NAIL WAS HAVING AN ISSUE ENGAGING THE LOCKING MECHANISM IN ORDER TO LOCK THE FENESTRATED SCREW. WHEN TAKING OUT THE NAIL AND TESTING IT, THE CONNECTING SCREW SPUN, BUT WHEN IN THE PATIENT THE MECHANISM WAS HAVING ISSUES. BOTH THE FLEXIBLE SCREWDRIVER AND STRAIGHT DRIVER SEEMED TO NOT ENGAGE PROPERLY AND AT THE END WE WERE ABLE TO LOCK DOWN THE SCREW AFTER MUCH TRIAL AND ERROR. IT WAS EXTREMELY DIFFICULT TO LOCK THE SCREW DOWN AND APPEARED TO NOT WORK PER USUAL. THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT TOOK MUCH LONGER DUE TO THE ISSUE, AROUND 2.5-3 HOURS.

  Patient problems: Insufficient Information

  MAUDE report 21733526 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REVISION SURGERY OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO NON-UNION. THE NAIL AND BLADE WERE REMOVED AND REVISE TO DHS. PROCEDURE AND PATIENT OUTCOME WAS SUCCESSFUL. THIS REPORT IS FOR 1 11MM/130 DEG TI CANN TFNA 320MM/RIGHT - STERILE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11942661 ↗

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-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-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-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