TFN-ADVANCE 04.037.145SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982096579), received between Jan 26, 2018 and Apr 25, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Break; Break

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21910703 ↗
• InjurySep 20, 2024Break; Crack; Material Deformation; Break; Crack; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE PRIMARY TORQUE NAIL FOR A HIP FRACTURE ON (B)(6) 2024. A TORQUE NAIL WAS IMPLANTED, A 105MM LAG SCREW WAS IMPLANTED, AND ALSO USED A 5MM LOCKING SCREW, 46MM IN LENGTH. THE PATIENT CAME FOR HIS APPOINTMENT AT THE OFFICE AND THE TORQUE NAIL HAD SHOWN SIGNS OF DEFORMING AT THE PROXIMAL END OF THE NAIL AT THE JUNCTION TO THE LAG SCREW INSERTION. UPON COMPLICATION, REVISION SURGERY WAS SCHEDULED, AND THE TORQUE NAIL WAS REMOVED AS THE TORQUE NAIL SHOWED SIGNS OF CRACKING AND BREAKING. THE NAIL WAS REMOVED, AND A NEW TORQUE WAS PLACED IN THE PATIENT, AND THE SURGEON REPLACED A LONG TORQUE NAIL. RE-IMPLANTED A 105MM LAG SCREW AND DISTAL LOCKING SCREW. THE SURGERY WAS SUCCESSFUL. NO COMPLICATION AND CORRECTIVE PROCEDURE WERE DONE AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 20267135 ↗
• InjuryNov 14, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN POSTOPERATIVE DATE A FEMORAL NAIL FRACTURED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) UNKNOWN FEMORAL NAIL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15792783 ↗
• InjuryApr 29, 2022Break; Break

  THIS IS 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH 235MM TFNA AND NON UNION AFTER 5 MONTHS OF SURGERY FOR AN INTERTROCH FRACTURE. THERE WAS ALSO A LATERAL FEMORAL WALL FRACTURE BELOW THE BLADE HOLE. THE NAIL BROKE AT THE PROXIMAL HOLE. THE NAIL AND BLADE WERE REMOVED AND REVISED TO A LONG TFNA AND LAG SCREW. THE STATUS OF THE PATIENT POST HARDWARE REMOVAL WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE 11/130 DEG TI CANN TFNA 235/LEFT - SILE DEVICE. THIS COMPLAINT INVOLVES TWO DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14250441 ↗
• InjuryFeb 10, 2022Break; Break

  IT WAS REPORTED THAT, THE TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA) IMPLANT BROKE. THIS REPORT IS FOR (1) 11/130 DEG TI CANN TFNA 235/LEFT - SILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 13507512 ↗
• InjuryJan 13, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BROKEN IMPLANT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AT BLADE NAIL JUNCTION AND NON-UNION. THE IMPLANTATION SURGERY WA PERFORMED ON (B)(6) 2020. THERE WAS PATIENT CONSEQUENCE REPORTED. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE: TFNA(PART# UNKNOWN; LOT#: UNKNOWN; QUANTITY: 1). UNKNOWN LOCKING SCREW (PART#: UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11165495 ↗
• InjuryOct 28, 2020Break; Break

  UPDATED CONCOMITANT DEVICE: TFNA FENESTRATED SCREW (PART 04.038.195, LOT 32P4633, QUANTITY 1).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10750643 ↗
• InjuryOct 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) FOLLOWS: IT WAS REPORTED THAT PATIENT HAD IMPLANT 6 MONTHS AGO, BUT PATIENT CAME BACK FOR REVISION SURGERY WITH BROKEN IMPLANT. THE FEMUR INTRAMEDULLARY TEAR SPLIT IN THE PROXIMAL PART, SO THE PATIENT HAD TO BE RE-ENGAGED AND IMPLANTED NEW OSTEOSINTESIS DE FEMUR WAS PLACED WITH AUGMENTATION WITH CEMENT. REMOVED THE BROKEN IMPLANT AND FIXATION THE FRACTURE. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE (PART#: 04.038.385S, LOT#: H554891, QUANTITY#: 1) TFNA END CAP (PART#0: 4.038.000S, LOT#2: L71281, QUANTITY#:1) LOCKING SCREW (PART#: 04.005.524, LOT#: 1L85371, QUANTITY#:1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9142215 ↗
• InjuryApr 16, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION NAILING DUE TO BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFN-ADVANCED) SHORT NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: TFNA HELICAL BLADES (PART: UNKNOWN; LOT: UNKNOWN; QUANTITY 1), LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8520261 ↗
• InjuryAug 21, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, HELICAL BLADE, AND LOCKING SCREW IN (B)(6) 2017. PATIENT UNDERWENT A REVISION OF THE TFNA HELICAL BLADE IN (B)(6) 2018 AS IT WAS TOO LONG. AT THE SAME TIME, THE DISTAL LOCKING SCREW BROKE BUT WAS LEFT IMPLANTED. IT WAS REPORTED THAT AT THE END OF (B)(6) 2018, THE TFNA NAIL BROKE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 AND REVISED TO A HIP PROSTHESIS. PATIENT STATUS REPORTED AS GOOD. THE REVISION OF THE TFNA HELICAL BLADE IN (B)(6) 2018 IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE REVISION DUE TO BROKEN NAIL. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED HELICAL BLADE 85MM (04.038.385S, LOT H554890, QUANTITY 1), 5.0MM LOCKING SCREW WITH T25 STARDRIVE 36MM FOR IM NAILS (04.005.526, LOT L732033, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE CANNULATED TFNA NAIL 235MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7800761 ↗
• InjuryJan 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD AN INTERMEDIATE LENGTH TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANTED APPROXIMATELY ONE YEAR AGO AT AN OUTSIDE HOSPITAL. PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING A FALL. THE IMPLANTED TFNA BROKE IN THE AREA WHERE THE HELICAL BLADE PASSES THROUGH THE NAIL. THE HELICAL BLADE WAS REMAINED IN APPROPRIATE POSITION. IT WAS SUSPECTED THAT THE PATIENT SUSTAINED A FEMORAL NECK FRACTURE IN THE FALL. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, WHERE THE SURGEON REMOVED A SINGLE INTACT LOCKING SCREW, AN INTACT HELICAL BLADE, AND THE BROKEN NAIL (TWO PIECES). THE PATIENT HAD A MODULAR DISTAL FIXATION STEM FROM ANOTHER COMPANY IMPLANTED AND A BI-POLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS WAS REPORTED AS STABLE. X-RAYS WERE TAKEN BUT NOT AVAILABLE. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 7222048 ↗

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-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