TFN-ADVANCE 04.038.215SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982098832), received between May 15, 2019 and Oct 23, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 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 A REMOVAL OF THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, LAG SCREW AND DISTAL LOCKING SCREW DUE TO HIP PAIN. DURING THE REMOVAL PROCEDURE, ALL DEVICES WERE SUCCESSFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 115MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10727773 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO HIP AND FEMUR PAIN ON (B)(6) 2019.

  Patient problems: No Code Available; Pain

  MAUDE report 8836802 ↗
• InjuryMay 15, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REMOVAL DUE TO CATASTROPHIC FAILURE WITH PROTRUSION OF LAG SCREW INTO PELVIS. THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) FENESTRATED SCREW MIGRATED THROUGH THE TITANIUM CANNULATED (TFNA) NAIL AND INTO THE PELVIS. PATIENT FELL AND RAMMED THE TITANIUM CANNULATED (TFNA) NAIL. HOSPITAL HAS MAINTAINED CONTROL OF THE IMPLANT. TFNA IMPLANTS WERE REMOVED AND WERE REPLACED BY A TOTAL HIP ARTHROPLASTY (THA). THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. INITIAL IMPLANT DATE IS (B)(6) 2019. CONCOMITANT DEVICES REPORTED: UNKNOWN TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL (PART #: 04.037.042S, LOT #: H761295, QUANTITY # 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8613550 ↗

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