TFN-ADVANCE 04.038.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982098801), received between Dec 31, 2018 and Dec 18, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT REQUIRED A REMOVAL OF A TFNA NAIL BECAUSE IT HAD BROKEN. THE IMPLANT HAD BEEN IN THE PATIENT FOR THREE TO FOUR WEEKS. THE REVISION WAS PERFORMED BECAUSE THE PATIENT HAD A FEMUR FRACTURE. UPON INSPECTION OF THE RETURNED DEVICES ON DECEMBER 15, 2023, IT WAS NOTED THAT THE TI TFNA FENESTRATED SCREW AND THE LOCKING SCREW WERE STRIPPED. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 110MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351042 ↗
• InjuryAug 4, 2023Break; Break

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE IMPLANT BROKE IN A PATIENT. THERE WAS A NEED FOR REVISION. THE PATIENT'S CONSEQUENCES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 110MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17459988 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LEFT NAIL 14 X 400MM, 110MM FENESTRATED SCREW, AND TWO (2) DISTAL INTER-LOCKING SCREWS WERE REMOVED DUE TO BONE NON-UNION. PATIENT HAS CANCER. DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. IMPLANTS WERE REMOVED SUCCESSFULLY WITHOUT COMPLICATIONS. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 110MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11100553 ↗
• InjuryDec 31, 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 TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) HARDWARE WAS REMOVED DUE TO A FEMORAL NECK FRACTURE. BOTH THE TFNA NAIL AND LOCKING SCREWS WERE NOT BROKEN. THE PATIENT WAS REVISED/REPLACED WITH A HEMI-ARTHROPLASTY. THERE WAS AN UNSPECIFIED SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 110MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8206428 ↗

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