TFN-ADVANCE 04.038.420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982099372), received between Jul 9, 2020 and Jul 9, 2020 — classified as 1 injury.

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

• InjuryJul 9, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A RIGHT CEPHALOMEDULLARY NAIL. THE PATIENT RETURNED TO OR TO REMOVE A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL AND TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED HELICAL BLADE DUE TO BLADE CUT OUT. THE NAIL, HELICAL BLADE AND DISTAL LOCKING SCREW WERE REMOVED WITH NO DIFFICULTIES. ALL HARDWARE WAS INTACT, AND NO HARDWARE REMAINED IN THE PATIENT. THE RIGHT HIP WAS REVISED TO A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AT END OF PROCEDURE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), 12MM/130 DEG TITANIUM CANNULATED TFNA NAIL (PART # 04.037.244S, LOT # 38P4303, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 120MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10252356 ↗

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