TFN-ADVANCE 04.037.030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095886), received between Jul 6, 2020 and Jul 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER DRILLING FOR THE HELICAL BLADE, DURING A TFNA, OUR 10MM CANNULATED TAPERED DRILL BIT CAME OUT WITH METAL SHAVINGS. THEY TOOK OUT THE NAIL AND INSPECTED IT AND DISCOVERED THE SHAVINGS HAD CAME FROM THE NAIL. THE NAIL WAS REPLACED WITH A BRAND NEW ONE OF THE SAME KIND. THE TRAY WAS NOT PUT UP AGAIN FOR ANOTHER SURGERY UNTIL HARDWARE WAS INSPECTED. A NEW NAIL WAS OPENED AFTER CLEANING THE DRILL AND SURGERY SITE. IT STILL PRODUCED METAL SHAVING, ALTHOUGH FEWER. THE CORRECT NAIL FOR THE INSERTION ARM WAS USED AND CHECKED BOTH TIMES FOR ALIGNMENT. THE ISSUE WAS THAT THE NAIL'S INTEGRITY MAY HAVE BEEN COMPROMISED. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10/125 DEG TI CANN TFNA 400/RIGHT - SILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704987 ↗
• MalfunctionFeb 17, 2023Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN FEBRUARY 2023, THERE WAS A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. THIS REPORT IS FOR AN UNKNOWN TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396218 ↗
• InjuryJul 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF A RIGHT LONG PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL THAT BROKE AT THE SCREW/BLADE HOLE IN THE PROXIMAL END. THE NAIL WAS IMPLANTED ON (B)(6) 2019 FOR PROPHYLACTIC FIXATION OF RIGHT FEMUR CANCEROUS LESION. THE NAIL, SCREW AND BOTH DISTAL LOCKING SCREWS WERE REMOVED COMPLETELY WITH NO ISSUES. ONLY THE NAIL WAS BROKEN. A NEW LARGER TFNA NAIL WAS REINSERTED AND LOCKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED SCREW (PART #: 04.038.190S, LOT # UNKNOWN, QUANTITY 1), UNKNOWN DISTAL LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10233485 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, 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
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima