TFN-ADVANCE 04.037.051SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982096074), received between Sep 24, 2022 and Jul 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Break; Break

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TFNA NAIL AND BLADE IN QUESTION GOT BROKEN UP. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 300MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335327 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP EVENT REMOVAL OF THE HARDWARE/EXPLANT WILL BE DONE DUE TO FAILURE. 90 Y/O IT FRACTURE HAD A TFNA IMPLANTED BY SURGEON ABOUT A MONTH AGO. LAG SCREW FAILED AND PENETRATED THE ACETABULUM. WE STARTED USING THE STATIC TORQUE LIMITING SET SCREWDRIVER A FEW MONTHS AGO TO CONFIRM SET SCREW IS SEATED, BUT THIS ISSUE STILL OCCURRED. IT IS UNKNOWN IF THE FAILURE WAS DUE TO BONE QUALITY, TECHNIQUE, OR IMPLANT FAILURE. THE IMPLANT WILL BE REMOVED TOMORROW (B)(6) 2022. PATIENT WAS EXPERIENCED POST-OP MALFUNCTION WHICH IS LAG SCREW MEDIALIZED AND CUTOUT INTO THE ACETABULUM. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 10/130 DEG TI CANN TFNA 300/LEFT - SILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15481056 ↗

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-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-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-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