TFN-ADVANCE 04.038.420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982099365), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY TOOK PLACE (B)(6) 2022 TO A FAILED BROKEN IMPLANT. THE SURGEON WILL BE REMOVING A SYNTHES NAIL AND COVERING TO A TOTAL HIP. ORIGINAL IMPLANT DATE NOT KNOWN. THE HARDWARE WAS SUCCESSFULLY REMOVED. THE NAIL WAS BROKEN AT THE HELICAL BLADE SITE. ALL FRAGMENTS WERE REMOVED. THE PATIENT WAS POSITIVE FOR INFECTION. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR THE TFNA BLADE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15086410 ↗

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-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