TFN-ADVANCE 04.038.210SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982098818), received between Apr 24, 2020 and Aug 26, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 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.

• MalfunctionAug 26, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR RIGHT FEMORAL TROCHANTERIC FRACTURE WITH TFNA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. POSTOPERATIVELY, THE PATIENT PROGRESSED SMOOTHLY. HOWEVER, THE PATIENT COMPLAINED OF PAIN, SO AN X-RAY WAS REVIEWED ON (B)(6), 2025, AND IT WAS CONFIRMED THAT A CUT-OUT HAD OCCURRED. THE CAUSE WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22896134 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY BECAUSE WHILE AT A FACILITY WHILE TRANSFERRING BEDS, THE PATIENT WAS DROPPED, RESULTING IN ANOTHER FRACTURE. 11MM/130 DEG TI CANN PROXIMAL FEMORAL NAILING SYSTEM (TFNA), TFNA FENESTRATED SCREW, AND 5.0MM TI LOCKING SCREW WERE REMOVED. THEY WERE NOT BROKEN; THEY WERE IN PLACE. THE TFNA WAS REMOVED AND EXCHANGED FOR A LONGER NAIL. THERE WAS NO INFECTION OR BROKEN IMPLANTS. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1)TFNA FENESTRATED SCREW 110MM STERILE. THIS REPORT IS 2 OF 3 FOR (B)(4).

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

  MAUDE report 12198801 ↗
• InjuryOct 23, 2020Migration; Migration

  UPDATED CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED TFNA-STERILE (PART 04.037.042S, LOT 47P3301, QUANTITY 1), TITANIUM LOCKING SCREW WITH T25 STARDRIVE (PART 04.005.528S, LOT 53P7168, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 10730310 ↗
• MalfunctionApr 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) FENESTRATED SCREW HAS COLLAPSED AFTER BEING LOCKED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE COMPLAINT WAS GENERATED FROM THE FOLLOW UP VISIT. THE SURGEON NOTICED COLLAPSE AFTER LOCKING THE DEVICE DURING THE INITIAL SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (2) DEVICE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996035 ↗

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