TFN-ADVANCE 04.038.075SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098412), received between Jan 19, 2018 and Jun 5, 2018 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WHICH INCLUDES ONE (1) NAIL AND TWO (2) 5MM LOCKING SCREWS ON (B)(6) 2018 DUE TO PAIN AT THE TROCHANTERIC REGION. THE TFNA WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WAS NOTED TO HAVE HEALED AND THE DEVICES WERE REMOVED INTACT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE; THE PATIENT OUTCOME WAS REPORTED AS OKAY/COMPLETE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7569356 ↗
• InjuryJan 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 DUE TO SUPERIOR CUT-OUT OF THE LAG SCREW. THE ORIGINAL RIGHT SIDED TFNA PROCEDURE WAS PERFORMED ON (B)(6) 2017. THE NAIL, THE LAG SCREW AND A DISTAL LOCKING SCREW WERE ALL REMOVED INTACT. A TOTAL HIP ARTHROPLASTY WAS PERFORMED AFTER REMOVAL OF THE HARDWARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICES REPORTED: 9MM/125 DEG TI CANN TFNA 340MM/RIGHT-STERILE (PART # 04.037.924S, LOT # UNKNOWN, QTY # 1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS (PART # 04.005.532, LOT # UNKNOWN, QTY # 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7207470 ↗

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-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