TFN-ADVANCE 04.037.165SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982096739), received between Oct 3, 2018 and Sep 25, 2026 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility

  It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised/did not lock in surgeries. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900096 ↗
• InjuryMar 18, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF IMPLANTS DUE TO BROKEN TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL. ORIGINALLY THE PATIENT WAS IMPLANTED WITH TFNA NAIL, BLADE, AND BOLT ON AN UNKNOWN DATE. ALL IMPLANTS WERE REMOVED AND CONVERTED TO BLADE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY DURING REVISION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (PART# 04.038.410, LOT# UNKNOWN, QUANTITY 1). UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9849746 ↗
• InjuryOct 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS SCHEDULED TO UNDERGO A REPLACEMENT OF 105MM HELICAL BLADE DUE TO DISCOMFORT IN THE PATIENT. WHEN THE BLADE WAS REMOVED, IT WAS NOTICED THE TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) WAS BROKEN AT THE NAIL JUNCTION BLADE INTERFACE. BOTH THE NAIL AND HELICAL BLADE WERE REMOVED AND REPLACED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: DISTAL LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), TFNA BLADE (PART: 04.038.305S, LOT: UNKNOWN, QUANTITY: 1).

  Patient problems: Discomfort; Failure of Implant; No Code Available

  MAUDE report 7930333 ↗

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