TFN-ADVANCE 04.038.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098825), received between Nov 25, 2020 and Mar 2, 2023 — 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.

• InjuryMar 2, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POST-OP, THE PATIENT INITIALLY BROKE HIS PROXIMAL FEMUR, AND HAD A SYNTHESE TROCHANTERIC FIXATION NAIL ADVANCED(TFNA) INSERTED TO FIX FRACTURE. THE PATIENT FAILED TO HEAL FROM ORIGINAL INJURY AND THE LAG SCREW CUT OUT OF THE FEMORAL HEAD. PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING AFTER THE SECOND SURGERY WHICH WAS COMPLETED ON (B)(6) 2023 FOR A TOTAL HIP REPLACEMENT. THE TFNA WAS EXPLANTED DUE TO NONUNION/FAILURE AND THE PATIENT REQUIRED REVISION SURGERY FOR REMOVAL OF TFNA TOTAL HIP REPLACEMENT. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 115MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16467128 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY FOR PROXIMAL FEMUR FRACTURE DUE TO MALUNION/NONUNION. TFNA WAS REMOVED AND A SMITH AND NEPHEW NAIL WAS THEN IMPLANTED IN PLACE ALONG WITH A 4.5MM PROXIMAL FEMUR HOOK PLATE. THE DATE OF THE ORIGINAL IMPLANT WAS UNKNOWN. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 115MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10905732 ↗

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