TFN-ADVANCE 04.038.410SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982099334), received between Jun 28, 2019 and May 19, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (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.

• InjuryMay 19, 2023Migration; Migration

  IT WAS REPORTED ON (B)(6) 2023 THE SURGEON REPORTED TO SALES REP THAT HE HAD A PATIENT REPORT TO CLINIC WITH PAIN IN THE HIP REGION. THE PATIENT HAD A TFNA IMPLANTED FOR A HIP FRACTURE ON (B)(6) 2023. UPON TAKING A NEW X-RAY, SURGEON SAW THAT THE HELICAL BLADE HAD ESCAPED THE NAIL LATERALLY CAUSING THE FEMORAL NECK TO COLLAPSE, REQUIRING A REVISION SURGERY. UPON REMOVING THE NAIL, WE FOUND THAT THE INTERNAL LOCKING MECHANISM WAS BROKEN. SURGEON PERFORMED THE REVISION SURGERY SUCCESSFULLY IMPLANTING ANOTHER TFNA NAIL AND HELICAL BLADE. SURGEON HAD REQUESTED THAT THE NAIL BE INVESTIGATED AND WOULD LIKE A REPORT BACK OF ANY FINDINGS. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 110 -S. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 16965431 ↗
• InjuryNov 7, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) SYSTEM. THE HELICAL BLADE CUT OUT MEDIALLY THROUGH THE FEMORAL HEAD ON AN UNKNOWN POSTOPERATIVE DATE. THE REVISION SURGERY OR HARDWARE REMOVAL HAS NOT DONE YET. NO FURTHER INFORMATION PROVIDED THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 110MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 12761119 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A NAIL REMOVAL WAS PERFORMED AND THE PATIENT WAS CONVERTED TO A BALL JOINT. THE ORIGINAL IMPLANTATION DATE IS UNKNOWN. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 110MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 12086693 ↗
• InjuryJun 28, 2019Material Twisted/Bent; Migration; Material Twisted/Bent; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION/ REMOVAL OF A TROCHANTERIC FEMORAL NAIL-ADVANCE TFNA CONSTRUCT DUE TO NONUNION AND PERFORATION OF THE FEMORAL HEAD. A HELICAL BLADE FROM A TFNA PERFORATED THROUGH THE FEMORAL HEAD AND THE ACETABULUM POSTOPERATIVELY. THE NAIL, HELICAL BLADE, AND LOCKING SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: 5.0 MM TITANIUM LOCKING SCREWS (PART: 458.940, LOT: H499571, QUANTITY: 1), TFNA NAIL (PART: 04.037.142S, LOT: H677513, QUANTITY: 1). THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8745272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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