TFN-ADVANCE 04.037.156SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982096647), received between Apr 9, 2019 and Sep 11, 2024 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIP OF RETENTION PIN FOR SCREWDRIVER QC HEX 12/SHT/XL25 WAS BROKE OFF AND TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL WAS CROSS THREADED/DAMAGED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11/130 DEG TI CANN TFNA 360/RIGHT - SILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20189941 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIP OF RETENTION PIN FOR SCREWDRIVER QC HEX 12/SHT/XL25 WAS BROKE OFF AND TROCHANTERIC FIXATION NAIL -ADVANCED (TFNA) NAIL WAS CROSS THREADED/DAMAGED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1)11/130 DEG TI CANN TFNA 360/RIGHT - SILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20189355 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIP OF RETENTION PIN FOR SCREWDRIVER QC HEX 12/SHT/XL25 WAS BROKE OFF AND TROCHANTERIC FIXATION NAIL -ADVANCED (TFNA) NAIL WAS CROSS THREADED/DAMAGED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11/130 DEG TI CANN TFNA 360/RIGHT - SILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20189087 ↗
• InjuryDec 1, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES, AND THE DEVICES WERE THEN REMOVED SEVERAL DAYS LATER DUE TO FAILURE. THIS REPORT INVOLVES ONE 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18245431 ↗
• MalfunctionFeb 28, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6), 2022, AFTER A TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) WAS PERFORMED, THE PROXIMAL END OF THE NAIL WAS SIGNIFICANTLY PROMINENT. NO OTHER ISSUES WERE NOTED RELATED TO THE IMPLANT. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13623213 ↗
• InjuryJun 29, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REMOVAL SURGERY OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO A BROKEN DEVICE ON (B)(6) 2021. THE BROKEN TFNA NAIL WAS REMOVED AND REPLACED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12087403 ↗
• InjuryNov 24, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF FEMORAL NAIL AND WAS CONVERTED TO TOTAL HIP DUE TO CUT OUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10896739 ↗
• InjuryApr 6, 2020Break; Break

  CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED HELICAL BLADE 90MM (PART: 04.038.390, LOT: H323826, QUANTITY 1) UNKNOWN LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 2).

  Patient problems: No Code Available

  MAUDE report 9931131 ↗
• InjuryAug 16, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION OF TFNA SYSTEM FOR TROCHANTERIC FIXATION LAST (B)(6) 2018. HOWEVER, THE REVERSE OBLIQUE FRACTURE DID NOT HEAL RESULTING TO BREAKAGE OF THE NAIL. DURING REMOVAL, ALL PIECES OF THE BROKEN NAIL, LAG SCREW AND UNKNOWN LOCKING SCREWS WERE REMOVED. THEN, THE PATIENT WAS REVISED TO A NEW NAIL IN A LARGER DIAMETER OF A TROCHANTERIC FIXATION NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA LAG SCREW (PART # 04.038.090, LOT # 7938535, QUANTITY # 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 2). THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8903604 ↗
• InjuryAug 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL. THE NAIL BROKE BELOW THE HELICAL BLADE AND THERE WAS NON-UNION FOR SIX (6) MONTHS AND DELAYED HEALING. DATE OF ORIGINAL IMPLANT WAS ON EARLY 2019. THE IMPLANTS WERE SUCCESSFULLY EXPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ALLEGATION WITH THE HELICAL BLADE, THE HELICAL BLADE WAS FINE. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN.  CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

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

  MAUDE report 8885916 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO NONUNION AND WAS REPLACED WITH A SYNTHES PIRIFORMIS FOSSA RECON NAIL ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT CONSEQUENCE WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 8574423 ↗
• InjuryApr 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, A RIGHT TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL HAD A MALFUNCTION WHEN THE SURGEON WAS TRYING TO PROXIMALLY LOCK THE LAG SCREW; ITS LOCKING MECHANISM WAS JAMMED SO THAT THE SURGEON COULD NOT LOCK IT, STATICALLY. THE SURGEON DECIDED TO OPEN A NEW RIGHT TFNA NAIL AND HAD TO PUT TWO ADDITIONAL 1.7MM CABLES ON BECAUSE THE FRACTURE SPLIT WHEN THE ORIGINAL NAIL WAS BEING REMOVED. BONE FRAGMENTS WERE GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: TFNA LAG SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); TFNA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), SCREWDRIVER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8495738 ↗

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-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