TFN-ADVANCE 04.038.300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982099037), received between Aug 14, 2018 and Apr 23, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 29, 2021, IT WAS CONFIRMED THAT THE PATIENT WHO UNDERWENT TFNA SURGERY AT THIS HOSPITAL ON JUNE 3, 2019 DEVELOPED WOUND INFECTION. THE SURGEON COMMENTED THAT THE DISTAL END OF THE TELESCOPED BLADE PROTRUDED INTO THE SKIN, WHICH MAY HAVE CAUSED A WOUND ON THE SKIN AND CAUSED AN INFECTION. SINCE BONE UNION HAS ALREADY BEEN ACHIEVED IN THIS CASE, NOT ONLY THE BLADE BUT ALSO ALL THE IMPLANTS WILL BE REMOVED IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FEM NAIL 12 125 L200 TI. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11719474 ↗
• InjuryJun 11, 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 REMOVAL OF THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM DUE TO MALREDUCTION/ NONUNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TFNA SYSTEM ON AN UNKNOWN DATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10143093 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONCOMITANT DEVICES: UNK - SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY: 2); 11MM/130 DEGREE TI CANN TFNA 380MM/RIGHT - STERILE (PART # 04.037.158S, LOT # H450364, QUANTITY 1).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10074723 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE TOTAL HIP DUE TO AVASCULAR NECROSIS (AVN) OF FEMORAL HEAD ON (B)(6) 2019. THE LONG PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE WAS IN THE PATIENT'S PELVIS. THE DEVICE WAS NOT BROKEN.  THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; No Code Available

  MAUDE report 8488157 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A REMOVAL OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO A FRACTURE THAT OCCURRED AT A POINT OF A STRESS RISER BETWEEN THE TFNA NAIL AND A VARIABLE ANGLE (VA) CONDYLAR PLATE. THE TFNA NAIL WAS EASILY REMOVED AND REPLACED WITH A NEW, LONGER TFNA NAIL WHICH EXTENDED BEYOND THE PLATE. AN UNKNOWN QUANTITY OF CABLES WERE ALSO PLACED TO AUGMENT THE CONSTRUCT, AS WELL AS AN UNKNOWN QUANTITY OF SCREWS. NO FRAGMENTS WERE PRODUCED. IT IS NOT KNOWN IF SURGERY WAS DELAYED. PATIENT OUTCOME IS NOT KNOWN. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 100MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7782679 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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-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-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