TFN-ADVANCE 04.037.258SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982097385), received between Jun 22, 2018 and Mar 17, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SET SCREW WOULD NOT GO DOWN AND THE NAIL WAS SWITCHED OUT. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619675 ↗
• InjuryFeb 4, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY OF TFNA DUE TO CUT OUT CONVERTED TO TOTAL HIP. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

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

  MAUDE report 13452139 ↗
• InjuryOct 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION AND HARDWARE REMOVAL WAS PERFORMED DUE TO A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL AND NON-UNION PROXIMAL FEMUR. THE PROCEDURE OUTCOME WAS UNKNOWN. PATIENT CONSEQUENCE NON-UNION FEMUR FRACTURE. CONCOMITANT DEVICES REPORTED: LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); END CAPS: TFNA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 10617435 ↗
• InjuryAug 11, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL AND REVISION SURGERY DUE TO A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL. THE PATIENT FELL AND THE IMPLANT BROKE ON AN UNKNOWN DATE. THE BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL WAS REPLACED WITH ANOTHER NEW PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THE ORIGINAL HARDWARE WAS IMPLANTED ON (B)(6) 2020. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED SCREW (PART# 04.038.190S, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10393082 ↗
• MalfunctionDec 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS UNABLE TO DISCONNECT TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL FROM THE CANNULATED CONNECTING SCREW. SURGEON REMOVED ALL IMPLANTS AND INSERTED A NEW NAIL ON A NEW HANDLE. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9402422 ↗
• InjuryApr 1, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF A LONG TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL THAT BROKE AT THE HELICAL BLADE/NAIL JUNCTION SEVERAL MONTHS AFTER BEING IMPLANTED ON (B)(6) 2018. IMPLANTATION WAS PERFORMED TO TREAT A HIP FRACTURE WITH REVERSE OBLIQUITY. DURING IMPLANTATION, THE INTERNAL LOCKING MECHANISM WAS LOCKED TO CREATE A FIXED ANGLE CONSTRUCT BETWEEN THE NAIL AND THE HELICAL BLADE. THERE WAS NO ADVERSE EVENT OR SURGICAL DELAY DURING IMPLANTATION. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: STERILE TFNA HELICAL BLADE (PART # 04.038.295S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8470831 ↗
• InjuryFeb 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF BROKEN TITANIUM CANNULATED TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL, STERILE AND TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) SCREW, STERILE DUE TO NONUNION AND DELAYED HEALING. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2018. HARDWARE WAS REMOVED AND TOTAL HIP REPLACEMENT DONE. THERE WAS ONE DISTAL LOCKING SCREW THAT WAS BROKEN IN HALF. THE PORTION WITH THE HEAD REMOVED AND THE REMAINING SHAFT PORTION RETAINED. THE NAIL WAS ALSO BROKEN AT THE CEPHALOMEDULLARY SCREW JUNCTION. BOTH PARTS OF THE NAIL WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS WAS STABLE. CONCOMITANT MEDICAL PRODUCTS: TFNA SCREW, STERILE (PART # 04.038.095S, LOT # H406587, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8357270 ↗
• InjuryNov 6, 2018Entrapment of Device; Malposition of Device; Device-Device Incompatibility; Entrapment of Device; Malposition of Device; Device-Device Incompatibility

  IT WAS REPORTED PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE ON (B)(6) 2018. SURGEON OPTED TO USE THE STATIC METHOD AND LOCKED THE LAG SCREW, CREATING A RIGID CONSTRUCT. SURGERY WAS COMPLETED SUCCESSFULLY. X-RAY TAKEN ON (B)(6) 2018 REVEALED THE LAG SCREW HAD MIGRATED INTO THE NAIL. THE DEVICES REMAIN IMPLANTED, NO REVISION PROCEDURE IS PLANNED.

  Patient problems: No Code Available

  MAUDE report 8043300 ↗
• InjuryJun 22, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2018. ONE TITANIUM (TI) CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND ONE TFNA HELICAL BLADE WERE REMOVED AND THE PATIENT WAS REVISED TO A TFN. THE ORIGINAL IMPLANTATION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AT A FOLLOW-UP APPOINTMENT ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF PAIN AND AN X-RAY WAS DONE WHICH REVEALED THE NAIL WAS BROKEN WITH NO MALFUNCTION OF THE BLADE. IMPLANTS WERE REMOVED WITHOUT DIFFICULTY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY. PATIENT'S STATUS IS STABLE. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE 10MM STERILE (PART: 04.038.300S, LOT: H540343, QUANTITY: 1) THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7630586 ↗

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