TFN-ADVANCE 04.038.410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982099327), received between Oct 16, 2018 and Jun 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryJun 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  07/15/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING MECHANISM IN THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL DID NOT LOCK THE UNKNOWN HELICAL BLADE IN PLACE AND THE HELICAL BLADE THEN ADVANCED MEDIALLY. THIS COULD HAVE BEEN CAUSED BY SURGEON ERROR DURING THE IMPLANT OR A FAILED LOCKING MECHANISM. THE IMPLANTS WERE REMOVED/EXPLANTED ON (B)(6) 2019. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: TITANIUM LOCKING SCREW (PART #: 458.940, LOT #: H499571, QUANTITY #: 1) . THIS COMPLAINT INVOLVES TWO (2) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8737357 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY OF PROXIMAL FEMUR DUE TO FEMUR FRACTURE. THE PLAN WAS TO IMPLANT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA). WHEN IT CAME TIME TO IMPLANT THE NAIL, THE NURSE LEFT THE ROOM TO GET A TROCHANTERIC FIXATION AND A NAIL. UPON HER RETURN SHE HAD A TFN INSTEAD OF A TFNA AND THE NAIL WAS IMPLANTED. A NEW TYPE OF HELICAL BLADE WAS IMPLANTED ALONG WITH A TFN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THE PATIENT IS STABLE AND DOING FINE. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS COMPLAINT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 110MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7970600 ↗

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