TFN-ADVANCE 04.038.295Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982099006), received between Oct 25, 2017 and Jan 27, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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.

• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALSO REPORTED THAT THE PATIENT WAS CONVERTED TO TOTAL HIP PROSTHESIS DUE TO NONUNION AFTER 6 MONTHS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11237640 ↗
• InjuryDec 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY SOMETIME IN (B)(6) 2017 FOR TREATMENT OF A LEFT FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA), ONE (1) HELICAL BLADE AND ONE (1) DISTAL LOCKING SCREW. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT PRESENTED WITH THE HELICAL BLADE IMPLANT CUTTING OUT OF THE FEMUR NECK BONE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A FEMUR PLATE AND SCREWS. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 11 MM/130 MM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (PART# 04.037.142S, LOT# UNKNOWN, QUANTITY 1). TFN-ADVANCED SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 95 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7147807 ↗
• InjuryOct 25, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL WITH REVISION ON (B)(6) 2017, DUE TO MIGRATION OF THE NAIL AND HELICAL BLADE. THE DATE OF THE ORIGINAL TFNA PROCEDURE IS UNKNOWN. THE NAIL, THE HELICAL BLADE AND ONE LOCKING SCREW, ALL INTACT, WERE REMOVED. THE PATIENT RECEIVED A TOTAL HIP PROSTHESIS AS THE REVISION. THERE WAS NO REPORTED SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE HARDWARE REMOVAL PART OF THE PROCEDURE. IT IS UNKNOWN THE OUTCOME OF THE REVISION PART OF THE PROCEDURE OR IF SURGICAL COMPLICATIONS OR DELAYS OCCURRED. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS ( QUANTITY 1), 11 MM/130 DEG TI CANN TFNA 380 MM/LEFT - STERILE (PART # 04.037.159S, LOT # H302282, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 95 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6977819 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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