TFN-ADVANCE 04.037.942SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982098023), received between May 23, 2018 and Jun 10, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY VIA TFNA AGMT AT ANOTHER HOSPITAL IN (B)(6) 2025 WITH THE IMPLANTS IN QUESTION. ON (B)(6) 2026, THE AGENCY CONTACTED TO REPORT A FRACTURE OCCURRED UNDER THE NAIL IN QUESTION. THE RE-OPERATION WITH CABLES AND PLATE IS SCHEDULED ON (B)(6) 2025, TO REMOVE ONLY THE TRANSVERSE RETAINING SCREW. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25456307 ↗
• InjuryJun 28, 2024Migration; Migration

  IT WAS REPORTED ON (B)(6) 2024, A REVISION SURGERY WAS COMPLETED DUE TO PATIENT NOT HEALING AT THE FRACTURE SITE AND HELICAL BLADE MIGRATION MEDIALLY. SURGEON REMOVED ALL THE IMPLANTS WITHOUT INCIDENT OR DIFFICULTY. ORIGINAL IMPLANT DATE UNKNOWN. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE 9MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19632462 ↗
• MalfunctionAug 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE. WHILE TIGHTENING THE LOCKING MECHANISM WITH A TORQUE DRIVER, THE SURGEON HEARD AN UNUSUAL NOISE. AT THE END OF THE PROCEDURE, THE SURGEON COULD NOT FULLY INSERT THE END CAP, IT PROTRUDED APPROXIMATELY 2-3 MM FROM THE NAIL. INSPECTION WITH AN IMAGE INTENSIFIER REVEALED THAT THE LOCKING MECHANISM HAD NOT ADVANCED FROM ITS ORIGINAL POSITION. THE SURGEON AGAIN ATTEMPTED TO LOCK THE LOCKING MECHANISM SEVERAL TIMES, BUT WAS UNABLE TO DO SO. THE PROCEDURE WAS COMPLETED WITHOUT LOCKING. THERE WERE APPROXIMATELY 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9MM/130 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479870 ↗
• InjuryAug 9, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS HARDWARE REMOVAL OF 9MM SHORT TFNA NAIL, NAIL BROKE THRU DISTAL LOCKING HOLE. REMOVED BROKEN NAIL, REVISED W/ LONG TFNA NAIL W/ AUGMENT. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED HELICAL BLADE 80MM (PART: 04.038.380; LOT# UNKNOWN; QUANTITY: (B)(4)). UNK - SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY# UNKNOWN) THIS REPORT IS FOR ONE (1) 9MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15193389 ↗
• InjuryMay 23, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSTRUCT CONSISTING OF A NAIL, HELICAL BLADE AND 5.0MM DISTAL LOCKING SCREW ON (B)(6) 2018 FOR AN INTERTROCHANTERIC FRACTURE. PATIENT PRESENTED TO ER ON AN UNKNOWN DATE COMPLAINING OF PAIN. X-RAYS WERE TAKEN AND A BROKEN NAIL WAS NOTED. THE NAIL BROKE AT THE NAIL AND HELICAL BLADE INTERFACE. THE PROXIMAL END OF THE NAIL BROKE COMPLETELY AWAY FROM THE DISTAL END. THERE WERE NO ISSUES WITH THE HELICAL BLADE OR LOCKING SCREW. BOTH DEVICES WERE INTACT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE NAIL WAS BROKEN PRIOR TO EXTRACTION. THERE WERE NO BONY FRAGMENTS GENERATED DURING EXTRACTION OR REVISION. ALL HARDWARE WAS EASILY REMOVED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN STANDARD FOR THE PROCEDURE. PATIENT WAS REVISED TO A LATERAL ENTRY NAIL WITH TWO (2) 6.5MM RECON SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE 100MM STERILE (PART # 04.038.300S, LOT # H528969, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9MM/130 D

  Patient problems: Failure of Implant; Pain

  MAUDE report 7538784 ↗

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-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-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-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-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-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