TFN-ADVANCE 04.037.056SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982096128), received between Dec 5, 2017 and Aug 19, 2026 — classified as 3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50320872 ↗
• MalfunctionJun 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TFNA NAIL WAS REVISED DUE TO SCREW BACK OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336078 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROCEDURE, IT APPEARED THAT THE FENESTRATED LAG SCREW MISSED THE TFNA NAIL WHEN USING THE 130 DEGREE AIMING ARM. THE LAG SCREW ENDED UP MISSING THE NAIL ANTERIOR CAUSING THE SURGEON TO FREE HAND THE LAG SCREW IN THE CORRECT PLACE. ALSO, THE TFNA HELICAL BLADE AND SCREW INSERTER BROKE WHILE TURNING THE SCREW. THE THREADED TIP SNAPPED OFF WHEN INSERTING. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 10/130 DEG TI CANN TFNA 360/RIGHT - SILE THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565408 ↗
• InjuryJul 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A LONG TFNA NAIL WITH LAG SCREW BROKE AT THE JUNCTION OF THE LAG SCREW AND THE NAIL. THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A TOTAL HIP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 14976943 ↗
• InjuryMar 16, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON REMOVED A BROKEN TFNA FROM A PATIENT. THE ORIGINAL IMPLANTATION DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN SCREWS: LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11495085 ↗
• MalfunctionApr 18, 2018Failure to Align; Mechanical Jam; Failure to Align; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT SURGERY. DURING THE SURGERY, WHILE USING THE HIP TFNA NAIL, THE SURGEON WENT TO TAKE THE LOCKING MECHANISM OF THE NAIL DOWN AND IT WOULDN¿T BUDGE. THEY WERE UNABLE TO SEE ON THE X-RAYS WHETHER THE NAIL WAS UP OR DOWN, SO THEY HAD TO TAKE THE BLADE AND NAIL OUT AND PUT THEM BACK IN AGAIN. THIS TIME, THE LOCKING MECHANISM MOVED WITHOUT A PROBLEM. DUE TO THIS, TWENTY-FIVE (25) MINUTES WERE ADDED TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 360MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440255 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2017 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A INTERTROCHANTERIC HIP FRACTURE. THE FRACTURE WAS CONFIRMED WITH X-RAYS. THE SURGEON TOOK THE PATIENT TO THE OPERATING ROOM ON (B)(6) 2017 AND PATIENT WAS IMPLANTED WITH A LONG TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL WITH HELICAL BLADE AND DISTAL LOCKING SCREWS. ON (B)(6) 2017, AN X-RAY DURING NORMAL FOLLOW UP SHOWED THE FEMORAL HEAD STARTING TO SLIGHTLY COLLAPSE. THE SURGEON ELECTED TO WAIT AND WATCH THE FRACTURE. X-RAY ON (B)(6) 2017 SHOWED FURTHER COLLAPSE OF THE HEAD INTO VARUS. ON (B)(6) 2017, SURGEON TOOK THE PATIENT BACK TO THE OPERATING ROOM TO REMOVE THE TFNA NAIL, THE TFNA HELICAL BLADE, AND TWO LOCKING SCREWS AND TOOK CULTURES. NONE OF THE IMPLANTS WERE BROKEN AND THE REMOVAL WAS A SUCCESS. A HEMI-ARTHROPLASTY WAS PERFORMED IN PLACE OF THE HARDWARE REMOVAL. CONCOMITANT PARTS: 5.0MM TI LOCKING SCREW WITH T25 STRARDRIVE 40MM F/IM NAIL (PART NUMBER: 04.005.530S, LOT NUMBER: H359595, QUANTITY 1), 5.0MM TI LOCKING SCREW WITH T25 STARDRIVE 38MM F/IM NAIL (PART NUMBER: 04.005.528S, LOT NUMBER: H329932, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEGREE TI CANNULATED TFNA 360MM/RIGHT - S

  Patient problems: No Code Available

  MAUDE report 7084307 ↗

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-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-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-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-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-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