TFN-ADVANCE 04.037.015SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982095732), received between Apr 30, 2021 and Jul 15, 2025 — classified as 2 injuries, 2 malfunctions.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON A TROCHANTERIC PART WITH TFNA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HOWEVER, SALES REP GOT A PHONE CALL FROM THE SURGEON, AND HE SAID ¿THE PATIENT UNDERWENT TFNA SURGERY ON MAY 1ST. THE AFFECTED SIDE IS THE RIGHT, BUT THE NAIL WAS USED WAS FOR THE LEFT. IS THERE ANY PROBLEM?¿ AFTER CHECKING THE USAGE HISTORY, IT WAS CONFIRMED THAT THE LEFT NAIL WAS BEING USED. THE DIFFERENCE IN NAIL SHAPE AND THE ASSOCIATED RISKS WERE EXPLAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509832 ↗
• MalfunctionJun 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. THE SURGEON INSERTED THE NAIL, LAG SCREW, AND INJECTED CEMENT. AFTER THAT, THE SURGEON INSERTED THE LOCKING SCREW AND ATTEMPTED TO INSERT THE END CAP, BUT THE END CAP COULD NOT BE INSERTED. THE SURGEON CONFIRMED THAT THE END CAP WAS INSERTED IN THE PROPER DIRECTION, BUT THE END CAP COULD NOT BE ENGAGED WITH THE NAIL. THE SURGEON TOOK OUT THE END CAP ONCE AND CHECKED IF THE LOCKING MECHANISM WAS TIGHTENED PROPERLY. THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM. THE SURGEON USED A SPARE END CAP, BUT THE SPARE END CAP COULD NOT BE PROPERLY ENGAGED WITH THE NAIL EITHER. THE SURGEON COMPLETED THE PROCEDURE WITHOUT AN END CAP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR AN TFNA NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470069 ↗
• InjuryMay 27, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND AS THE X-RAY SHOWS AN UNKNOWN TFNA NAIL APPEARS TO BE BROKEN. TFNA NAIL WILL BE REMOVED AND REVISED ON 05/03/2021. THERE WAS PATIENT CONSEQUENCES OF A POSSIBLE NON-UNION CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) 10/125 DEG TI CANN TFNA 235/LEFT - SILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11897726 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA FENESTRATED SCREW AND UNKNOWN LOCKING SCREW DUE TO NONUNION. WHILE TRYING TO UNLOCK THE TFNA FENESTRATED SCREW THE FLEXIBLE HEXAGONAL SCREWDRIVER BROKE. ALL THE IMPLANTED DEVICES ARE REMOVED. PATIENT OUTCOME WAS SUCCESSFUL. THIS REPORT CAPTURES THE POSTOP EVENT OF HARDWARE REMOVAL DUE TO NON-UNION AND RELATED COMPLAINT (B)(4) CAPTURES THE INTRAOP EVENT OF SCREWDRIVER BREAKAGE DURING REMOVAL. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11756434 ↗

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-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