TFN-ADVANCE 04.038.415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982099341), received between Jan 22, 2019 and Aug 3, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionAug 3, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SOUTH AFRICA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE HANDLE INSTRUMENT WAS FOUND TO BE DAMAGED AND WAS UNABLE TO FULLY FUNCTION AND ATTACH THE BLADE TO THE INSERTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A DELAY OF 15 MINUTES USING AN OFF-LABEL TECHNIQUE FOR INSERTION OF THE BLADE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 115MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156432 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS IMPLANTED WITH THE LONG INTRAMEDULLARY TITANIUM CANNULATED TFNA IN THE RIGHT FEMUR. POST-OPERATIVE, ON (B)(6) 2019, PATIENT UNDERWENT A TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) PROCEDURE DUE TO NON-UNION OF THE FRACTURE SITE. DURING THE REVISION SURGERY, THE TFNA WAS REMOVED AND TOTAL HIP WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8267638 ↗

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