TFN-ADVANCE 04.037.263SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982097439), received between Jun 14, 2019 and Jan 9, 2026 — classified as 9 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SET SCREW DID NOT TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021271 ↗
• InjuryOct 6, 2023Break; Break

  IT WAS FURTHER REPORTED THAT THE IMPLANT WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17886959 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS REMOVAL OF BROKEN TFNA AND REVISION OF PROXIMAL FEMUR TO NAIL/PLATE HYBRID CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 14999983 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL OF TFNA NAIL, LAG SCREW AND DISTAL SCREWS. TRANSITIONED/REVISED PATIENT TO A TOTAL HIP ARTHROPLASTY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 13515046 ↗
• InjuryApr 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE OF A PRODUCT TROCHANTERIC THAT BROKE INSIDE THE PATIENT. SURGEON REMOVED THE BROKEN IMPLANT BEFORE THE TOTAL HIP REPLACEMENT. THE DATE OF THE ORIGINAL SURGERY WAS ON (B)(6) 2020. THE PRODUCTS INVOLVED WAS A NAIL, THAT WAS BROKEN AND THE LIVE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED SCREW (PART# 04.038.190; LOT# 17P2186; QUANTITY: 1) UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE.THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 11740416 ↗
• InjuryFeb 10, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT ORTHOPEDIC PROCEDURE, THE PROXIMAL END OF THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL BROKE. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), TFNA SCREW (PART # 04.038.120, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 360MM / RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9688323 ↗
• InjurySep 13, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL AND TOTAL HIP ARTHROPLASTY DUE TO AN ADVANCED LEFT HIP OSTEOARTHRITIS WITH RETAINED HARDWARE FROM A PREVIOUS FRACTURE AND SIGNS OF AVASCULAR NECROSIS WITH EARLY COLLAPSE OF THE FEMORAL HEAD. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) DUE TO NON-DISPLACED LEFT HIP INTERTROCHANTERIC FEMUR FRACTURE IN (B)(6) 2018. HOWEVER, SIX (6) MONTHS AFTER THE IMPLANT SURGERY, THE PATIENT FAILED CONSERVATIVE MEASURES, INCLUDING ANTI-INFLAMMATORIES AND PAIN MEDICATIONS. MOREOVER, THE PATIENT ALSO HAD AN INTRA-ARTICULAR INJECTION WITHOUT RELIEF OF HIS PAIN AND THEN WAS ADMITTED TO THE HOSPITAL TO HAVE THE HARDWARE REMOVED AND CONVERTED TO A TOTAL HIP ARTHROPLASTY. THE SURGEON NOTED THAT THE LOCKING MECHANISM AND HOLE FOR THE HELICAL BLADE IN THE TFNA NAIL WAS BENT AND DEFORMED AND AN INSPECTION SHOWED A LARGE NOTCH ANTERIORLY. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: REAMING ROD (PART# 351.706S, LOT# H564327, QUANTITY# 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Arthritis; Necrosis; No Code Available; Pain

  MAUDE report 9032794 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019: UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN CLAMP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), HELICAL BLADE (PART #: 04.038.400S, LOT #: H771531), LOCKING SCREW (PART #: 458.946S, LOT #: 7781086) AND LOCKING SCREW (PART #: 458.950S, LOT #: H515126).

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 9011882 ↗
• InjuryJul 19, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL WITH NON-UNION OF SUBTROCHANTERIC FRACTURE INTRAMEDULLARY NAIL LEFT FEMUR. PATIENT PREVIOUSLY TREATED FOR FRACTURE DUE TO CANCER. PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION. NAIL BROKE AT PROXIMAL JUNCTION OF LAG SCREW. THE TFNA SCREW WAS INTACT AND SUCCESSFULLY REMOVED. PAIN WAS EXPERIENCED BEFORE REVISION SURGERY NOT AFTER. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2018. REMOVAL OF NAIL AND LAG SCREW WAS SUCCESSFUL AND PATIENT WAS IMPLANTED WITH TFN NAIL AND TFN LAG SCREW. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT CONSEQUENCES EXPERIENCED PAIN DUE TO BROKEN NAIL/NON-UNION OF THE FRACTURE SITE. CONCOMITANT DEVICES REPORTED: TFNA SCREW 115MM (PART# 04.038.115, LOT# UNKNOWN, QUANTITY# 1) UNKNOWN SCREWS: LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 8809126 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) AFTER THE LOSS OF REDUCTION IN SUBTROCHANTERIC FRACTURE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE REMOVED DEVICES WERE THE FOLLOWING; ONE (1) DEGREE TITANIUM CANNULATED TFNA, ONE (1) TITANIUM LOCKING SCREW 46MM, ONE (1) TITANIUM LOCKING SCREW 50MM AND ONE (1) TFNA FENESTRATED HELICAL BLADE. PATIENT WAS REVISED TO A NEW NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8699400 ↗

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-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-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