TFN-ADVANCE 04.038.220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982098856), received between Jul 28, 2023 and Jul 28, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE SURGEON IMPLANTED A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) TO TREAT PATIENT'S LEFT INTERTROCHANTERIC FRACTURE. DURING PROCEDURE THE SURGEON HAD A DIFFICULT TIME GETTING THE LATERAL OPENING DRILL AND THE 6/9MM STEP DRILL TO PASS THROUGH THE NAIL. HE PROCEEDED TO IMPLANT THE TFNA LAG SCREW AND ALSO IMPLANT THE DISTAL INTERLOCKING SCREWS. SURGEON DID NOT NOTICE ON INTEROPERATIVE X RAYS THAT THE LAG SCREW WAS ANTERIOR TO THE NAIL. UPON REVIEW OF THE POST OPERATIVE X RAYS SURGEON REALIZED THAT THE LAG SCREW WAS IMPLANTED ANTERIOR TO THE NAIL AND THAT IT DID NOT PASS THROUGH THE NAIL. IT WAS DETERMINED THAT THE NAIL WAS NOT ASSEMBLED TO THE INSERTION HANDLE CORRECTLY WHICH ALLOWED THE ANGLE GUIDE TO ROTATE AND MISS THE NAIL ANTERIOR. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 WHERE THE NAIL AND LAG SCREW WERE REMOVED WITHOUT ISSUE AND A NEW NAIL AND LAG SCREW WERE IMPLANTED IN THE CORRECT ORIENTATION. THE STATUS OF THE PATIENT AT THIS TIME IS THAT THEY ARE RECOVERING AND THE REVISION NAIL SURGERY WAS SUCCESSFUL. THERE WAS NO DELAY DURING THE REVISION PROCEDURE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 120MM - STERILE. THIS IS REPORT

  Patient problems: Insufficient Information

  MAUDE report 17417105 ↗

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