TFN-ADVANCE 04.037.257SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982097378), received between Mar 22, 2019 and Aug 15, 2022 — classified as 8 injuries, 1 malfunction.

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.

• InjuryAug 15, 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 REMOVAL OF TFNA WAS PERFORMED, IN PREPARATION FOR THA REMOVAL. THIS REPORT INVOLVES ONE (1) 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 15224066 ↗
• MalfunctionMar 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. THE SURGEON WAS OPERATING A PATIENT AND WAS INSERTING A LEFT FEMUR NAIL, WHILE INSERTING THE HELICAL BLADE, IT WAS DETERMINED THAT THE ALIGNMENT WAS OFF. THE NAIL AND BLADE WERE REMOVED AND CHECKED WITH THE AIMING ARM AND INSERTION HANDLE ON BACK TABLE. IT WAS DETERMINED THAT THE INSERTION HANDLE WAS BENT. ANOTHER SET WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) TFNA NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928401 ↗
• InjuryDec 18, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, REVISION SURGERY WAS PERFORMED, REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) WITH RE-IMPLANTATION OF A COMPETITOR PRODUCT. INTRA-OP, IT WAS DETERMINED THAT THE IMPLANT WAS BROKEN, AND THE PATIENT HAD A NONUNION. REMOVAL OF THE BROKEN IMPLANT CAME OUT WITHOUT INCIDENT. RE-IMPLANTATION WENT OFF WITHOUT INCIDENT. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE ORIGINAL DATE OF IMPLANTATION WAS UNKNOWN. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE NON-UNION, DUE TO THE BROKEN IMPLANT, THE PATIENT NEEDED REVISION SURGERY TO REMOVE A BROKEN IMPLANT AND RE-IMPLANT ANOTHER DEVICE TO FIX NON-UNION. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE (PART# 04.038.395S, LOT# 33P9683, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11041140 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PATIENT WITH LONG TFNA FELL IN REHAB AND SUFFERED A DISPLACED DISTAL FEMUR FRACTURE. THE LONG NAIL WAS REPLACED WITH SHORT NAIL AND A VARIABLE ANGLE LOCKING COMPRESSION PLATE DISTAL FEMUR PLATE WAS APPLIED DISTALLY. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2020. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 12MM/ 130 DEG TI CANN TFNA 360MM/ LEFT-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10011728 ↗
• InjuryFeb 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF BROKEN INTRAMEDULLARY NAIL LEFT FEMUR AND REVISION OPEN REDUCTION, INTRAMEDULLARY AND EXTRAMEDULLARY FIXATION LEFT SUBTROCHANTERIC FEMUR FRACTURE. ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTRAMEDULLARY STABILIZATION FOR A LEFT SUBTROCHANTERIC FEMUR FRACTURE. THE PATIENT'S LEFT SIDE WAS IMPLANTED WITH A TFNA PROXIMAL FEMORAL NAIL BUT HAS FAILED AFTER TWO MONTHS AND FOUR DAYS DUE TO NAIL COMPLETELY BREAKING WHILE WALKING IN THE KITCHEN IN THE PRESENCE OF THE PATIENT'S AT-HOME PHYSICAL THERAPIST.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9752102 ↗
• InjuryAug 30, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, IT WAS A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) BROKE ONTO THE PROXIMAL INTO THE NAIL DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FEMUR - TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) REVISION PROCEDURE. THE REASON FOR THE IMPLANTATION WAS DUE TO BROKEN FEMUR. THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) NAIL BROKE PROXIMALLY. THE SURGEON HAD TO PULL OUT THE WHOLE TFN AND REPLACED IT WITH NEW TFN. CASE WAS FINE. PATIENT WAS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8950578 ↗
• InjuryJul 29, 2019Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS FURTHER REPORTED THAT PATIENT¿S PAIN BEGAN ON (B)(6) 2019 AND PATIENT PRESENTED TO HOSPITAL ON (B)(6) 2019. CONCOMITANT DEVICES: TFNA LAG SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2), CABLE WIRE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8837879 ↗
• InjuryJul 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LEFT NAIL WHICH BROKE JUST BELOW THE LAG SCREW. THE PATIENT WAS REVISED TO A NEW TFNA AND 4.5MM LOCKING COMPRESSION PLATE (LCP) NARROW PLATE, 3.5MM LOCKING ATTACHMENT PLATE, 3.5MM CORTEX SCREWS QUANTITY OF FOUR, AND 1.7MM CABLE WITH TWO (2) CERCLAGE PINS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: TFNA LAG SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 12MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8760751 ↗
• InjuryMar 22, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH BROKEN TITANIUM CANNULATED ADVANCE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) AND NONUNION. THE HARDWARE WAS REMOVED SUCCESSFULLY, AND ALL PARTS WERE RECOVERED. PATIENT WAS REVISED TO A NEW NAIL. ORIGINAL SURGERY WAS ON (B)(6) 2018. A NEW NAIL WAS IMPLANTED. PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT WAS DOING FINE. CONCOMITANT DEVICES: TFNA FENESTRATED HELICAL BLADE (PART: 04.038.390, LOT: H323579, QUANTITY: 1), DISTAL LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8445163 ↗

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-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-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