TFN-ADVANCE 04.037.013SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095718), received between Aug 30, 2022 and Jul 27, 2026 — classified as 1 injury, 2 malfunctions.

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

• InjuryJul 27, 2026Device-Device Incompatibility

  It was reported on (b)(6) 2026 that HCP chose a 10/200mm 125 degree TFNA implant to treat patient. With proper technique, the TFNA was inserted into the patient and the next step to put the lag screw in proceeded. Guidewire and step reamer passed through the tfna implant appropriately but when it was time to put the lag screw implant in, the lag screw stop advancing and metal grinding noises were heard. Lag screw was removed and inserted again with the same result. After removing the now damaged lag screw, the instrumentation was checked over and it was confirmed that everything was properly assembled and nothing came loose throughout the course of the procedure. A new lag screw was chose and insertion was attempted again. This time the lag screw threads became stuck inside the TFNA and time was spent disengaging the the two implants with much difficulty and some damage to the lag screw instrumentation.A third new lag screw was chosen and insertion was attempted free handed in case the cannula became fault but failed as well. We removed al implants and instruments and a new TFNA implant was chosen assembled. From there, all instrumentation worked properly and the procedure was comp

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034565 ↗
• MalfunctionAug 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE 125 DEGREE AIMING ARM AND 125 DEGREE NAIL WAS USED BUT THE HELICAL BLADE DID NOT FULLY INSERT THROUGH THE NAIL, THE NAIL WOULD NOT COMPLETE THE INSERTION. SO EVERYTHING WAS REMOVED AND THEY ENDED UP USING A NEW NAIL AND NEW HELICAL BLADE AND THEN EVERYTHING WORKED PERFECTLY. THIS REPORT IS FOR 10MM/125 DEG TI CANN TFNA 200MM - (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605477 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. A GUIDE WIRE FOR HEAD ELEMENTS SEEMED TO INTERFERE WITH THE NAIL WHEN THE SURGEON WAS INSERTING THE GUIDE WIRE USING THE INSERTION HANDLE AND AIMING ARM. THE SURGEON TRIED INSERTING THE GUIDE WIRE BY PUSHING IT A LITTLE STRONGER, THEN THE GUIDE WIRE GOT STUCK AND COULD NOT BE REMOVED. BUT THE SURGEON MANAGED TO REMOVE THE GUIDE WIRE AND TRIED TO INSERT ANOTHER NEW GUIDE WIRE AFTER CHECKING THE CONNECTION BETWEEN THE INSTRUMENTS AND REVERSED THE LOCKING MECHANISM OF THE NAIL TO REDUCE THE RISK OF INTERFERENCE. THE SURGEON MANAGED TO SUCCEED IN INSERTING THE GUIDE WIRE. AFTER THAT, THE SURGEON ALSO HAD A DIFFICULTY IN USING A REAMER WITH THE INSERTION HANDLE AND AIMING ARM. ALTHOUGH THE REAMER WENT FORWARD ONLY A LITTLE, IT STILL WENT FORWARD TO SOME EXTENT, SO THE SURGEON TRIED TO INSERT A BLADE. HOWEVER, EVEN WHEN THE SURGEON MANUALLY PUSHED THE BLADE, IT DID NOT REACH THE NAIL, SO THE SURGEON ADJUSTED THE OPERATION BY LIFTING THE INSERTION HANDLE A LITTLE AND PROCEEDED REAMING AGAIN. THE SURGEON SUCCEEDED IN REAMING, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322701 ↗

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