TFN-ADVANCE 04.037.154SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982096623), received between Dec 14, 2017 and Mar 20, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, REVISION SURGERY WAS PERFORMED ON A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) SYSTEM DUE TO A SUBTROCHANTERIC NONUNION. THE PROCEDURE OUTCOME WAS UNKNOWN. THE PATIENT WAS DOING WELL AND THERE WAS NOTHING WRONG WITH THE ORIGINAL TFNA NAIL, BLADE OR SCREW. PATIENT WAS REVISED TO 12MM TFNA NAIL. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), TFNA END CAPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN TFNA NAIL. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 9860676 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A NAIL AND HELICAL BLADE ON (B)(6)2017 DUE TO NONUNION AND BROKEN NAIL. FRAGMENTS WERE GENERATED FROM BROKEN DEVICE AND REMOVED EASILY, WITHOUT ADDITIONAL INTERVENTION. THE NAIL WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN 2015. THE NAIL WAS DISCOVERED BROKEN ON AN UNKNOWN DATE. THE NAIL AND HELICAL BLADE WERE REMOVED AND THE PATIENT WAS REVISED TO A DEPUY TOTAL HIP. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT MEDICAL DEVICE HELICAL BLADE (PART 04.038.300, LOT 7981965). THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7118176 ↗

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-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-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