TFN-ADVANCE 04.038.175SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098672), received between Jul 22, 2024 and Jun 12, 2025 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A TFNA IMPLANTED ON THE (B)(6) 2024. THE TFNA SCREW WAS EXCHANGED ON THE (B)(6) 2025 DUE TO PAIN. SINCE THEN, THE FEMORAL NECK HAS COLLAPSED WITH SIGNIFICANT SHORTENING. THE TFNA IS NOW BEING REMOVED AND REVISED TO A HEMIARTHROPLASTY. THE SURGEON HAS ACKNOWLEDGED THIS IS NOT AN IMPLANT FAILURE, BUT A RESULT OF THE PATIENT¿S BONE PHYSIOLOGY.

  Patient problems: Necrosis; Physical Asymmetry

  MAUDE report 22199499 ↗
• InjuryJul 22, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. ON JUNE 21, 2024, THE PATIENT COMPLAINED OF PAIN, AND X-RAYS REVEALED PENETRATION OF THE LAG SCREW. ON (B)(6) 2024, A REMOVAL SURGERY WAS PERFORMED. IN THE REMOVAL SURGERY, ONLY THE LAG SCREW WAS REMOVED. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED AS FOLLOWS: THE FIXATION WAS HIGHLY UNSTABLE SINCE THE PATIENT HAD AN ADVANCED OSTEOPOROSIS WITH CRUSHED BONE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 75MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 19792285 ↗

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