TFN-ADVANCE 04.038.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982099303), received between Jul 9, 2019 and Nov 16, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A BROKEN TFNA IMPLANT. THE ORIGINAL PROCEDURE WAS DONE ON (REMOVED). THE ORIGINAL INJURY WAS A COMMINUTED INTERTROCHANTERIC AND SUBTROCHANTERIC FRACTURE RESULTING FROM A SLIP AND FALL. THE TFNA LOCKING DEVICE WAS LEFT ENGAGED. IT APPEARS THAT THE FRACTURE DID NOT HEAL PRIOR TO THE IMPLANT FAILING. NO INFORMATION IS CURRENTLY AVAILABLE AS TO WHETHER OR NOT THE PATIENT HAD ANOTHER FALL AND/OR ACCIDENT THAT MAY HAVE CAUSED THE IMPLANTS TO FAIL. THE BROKEN IMPLANTS WERE RECOVERED AND WILL BE SENT IN FOR ANALYSIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. THE REASON FOR REVISION SURGERY WAS A BROKEN IMPLANT. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 105MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18151952 ↗
• InjuryFeb 17, 2023Migration; Migration

  IT WAS REPORTED THAT THE ORIGINAL SURGERY TO IMPLANT THE TFNA NAIL AND HELICAL BLADE OCCURRED ON (B)(6) 2022. THEN, THE TFNA HELICAL BLADE MIGRATED MEDIALLY INTO THE ACETABULUM, AND THE NAIL, HELICAL BLADE, AND DISTAL SCREW WERE REMOVED ON (B)(6) 2023. THE PATIENT WAS CONVERTED TO A TOTAL HIP ARTHROPLASTY.

  Patient problems: Failure of Implant

  MAUDE report 16400680 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NONUNION FROM A PREVIOUS SURGERY IN THE FEMORAL SHAFT/PROXIMAL FEMUR WAS DISCOVERED. THE SURGEON REMOVED A TFNA DEVICE, USED THE RIA TO COLLECT BONE GRAFT, AND THEN INSERTED A 95 DEGREE BLADE PLATE TO CORRECT THE NONUNION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 105MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13253452 ↗
• InjuryOct 18, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A TFNA REMOVAL WHERE THE BLADE HAS MIGRATED MEDIAL. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 105MM. THIS REPORT IS 2 OF 2 OF (B)(4).

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

  MAUDE report 12647256 ↗
• InjuryJul 9, 2019Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HELICAL BLADE CUT THROUGH THE FEMORAL HEAD. PATIENT WAS REVISED TO A TOTAL HIP. PROCEDURE AND PATIENT STATUS/OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES: 11MM/130 DEG TITANIUM (TI) CANNULATED TROCHANTERIC FIXATION NAIL- ADVANCED (TFNA) 170MM (PART: 04.037.142S, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8771387 ↗

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