TFN-ADVANCE 04.037.112SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982096302), received between Aug 25, 2020 and Mar 2, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) - INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482050 ↗
• MalfunctionJul 10, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH TFNA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS CONTACTED BY THE SURGEON THAT THE TFNA WAS SCHEDULED FOR REMOVAL. WHEN THE SALES REPRESENTATIVE CHECKED THE DETAILS, IT WAS FOUND THAT BECAUSE THE BLADE WAS ON THE VERGE OF PERFORATING THE FEMORAL HEAD, THE TFNA WAS SCHEDULED TO BE REMOVED ON (B)(6) 2025, AND REPLACED WITH A BHA. THIS EVENT WAS CAUSED BY POOR REDUCTION, WHICH RESULTED IN POSTERIOR INSERTION OF THE NAIL AND THE BLADE BEING INSERTED FROM THE POSTERIOR TO THE ANTERIOR PART OF THE NECK. THE SURGEON OPINED THAT THE EVENT WAS DUE TO TECHNICAL ISSUES, NOT PRODUCT-RELATED, CAUSED BY POOR REDUCTION AND POOR PLACEMENT OF THE IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22474094 ↗
• MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN PASSING THE CEPHALIC SCREW, SURGEON PROCEEDED TO BLOCK IT AS INDICATED BY THE TECHNIQUE AND WE CHECKED THAT IT HAD BEEN BLOCKED, BUT IT CONTINUED ROTATING, THE SYSTEM DOES NOT BLOCK EVEN IF WE GIVE THE TORQUE WITH THE TORQUE SCREWDRIVER OF 6 NM. SURGEON REMOVED EVERYTHING FROM THE PATIENT AND CHECKED THE NAIL ON THE SURGICAL TABLE AND SEE THAT IT DOES NOT ALLOW A CORRECT BLOCK EITHER. ANOTHER NAIL WAS PASSED TO THE TABLE SINCE THE OTHER ONE PRESENTED FAULTS IN THE CEPHALIC BLOCKING SYSTEM, AND PROCEEDED TO FINISH THE OSTEOSYNTHESIS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115029 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 ALL IMPLANTS WERE REMOVED DUE TO NONUNION, TRANSITIONED TO TOTAL HIP ARTHROPLASTY. THIS REPORT INVOLVES ONE (1) 11MM/125 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20004569 ↗
• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE WHEN THEY WERE PUTTING IN A TFNA, IT WAS FOUND THAT THE SET SCREW IN THE NAIL WAS DEFECTIVE AND IN THAT MOMENT, THE FLEXIBLE SCREWDRIVER BROKE WHILE TRYING TO FIX THE SET SCREW. THEY WILL SENDING THE SET SCREW BACK AS WELL. THE SET SCREW IN THE NAIL WAS NOT FULLY ENGAGING WITH THE LAG SCREW, CAUSING THE LAG SCREW TO NOT LOCK IN, RESULTING IN CATASTROPHIC END RESULTS IF LEFT IN THE PATIENT. SO WE REPLACED THE NAIL IN SURGERY AND WOULD LIKE TO HAVE A REPLACEMENT TO COMPENSATE. I WILL BE RETURNING THE NAIL AS WELL. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 45 MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)11/125 DEG TI CANN TFNA 170 - STERILE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606540 ↗
• MalfunctionFeb 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS WITH THE TFNA FOR THE INCOMPLETE FRACTURE OF THE TROCHANTERIC FEMUR. INSERTION OF THE NAIL AND THE BLADE WAS PERFORMED SMOOTHLY, AND THE LOCKING MECHANISM WAS LOCKED EASILY. AFTER INSERTION OF THE LOCKING SCREW, THE END CAP COULD NOT BE INSERTED INTO PROPER POSITION. THE LOCKING MECHANISM WAS UNLOCKED WITH THE SCREWDRIVER AND TIGHTENING OF LOCKING MECHANISM WAS REPEATED. THEN, THE SURGEON TRIED TO INSERT THE END CAP; HOWEVER, IT COULD NOT BE INSERTED. THEREFORE, ALL THE IMPLANTS WERE REMOVED, AND THE SURGEON CHECKED THE LOCKING MECHANISM. WHEN THE SURGEON TRIED TO TIGHTEN THE LOCKING MECHANISM, IT WAS HARD. IT REQUIRED MORE FORCE THAN USUAL TO TIGHTEN THE LOCKING MECHANISM. THE NAIL WAS CHANGED TO A DIFFERENT SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 20 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 11MM/125 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362116 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THEY REMOVED A TFNA SHORT NAIL OUT OF A PATIENT. THE PATIENT WAS EXPERIENCING SOME SOFT TISSUE IRRITATION DUE TO BONY OVERGROWTH OVER THE NAIL OF THE PROXIMAL HEAD. A TFNA LAG SCREW WAS ALSO REMOVED. THE NAIL WAS ORIGINALLY PUT IN ON (B)(6) 2017. LABORATORY TESTS WERE TAKEN DUE TO CLINICAL FINDINGS AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THIS REPORT IS FOR ONE (1) 11/125 DEG TI CANN TFNA 170 - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14957874 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT SURGERY FOR A RIGHT HIP INTERTROCHANTERIC FRACTURE. THE PATIENT WAS IMPLANTED WITH TFNA NAIL TO TREAT THE INTERTROCHANTERIC FRACTURE. ON OR ABOUT (B)(6) 2021, THE PATIENT EXPERIENCED HARDWARE FAILURE OF THE SYNTHES NAIL AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2021. THIS REPORT IS FOR (1) 11/125 DEG TI CANN TFNA 170 - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12990668 ↗
• MalfunctionAug 25, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED ON (B)(6) 2020 THAT THE FACILITY RECEIVED PRODUCTS THAT WERE DAMAGED DURING SHIPPING. IT WAS REPORTED THAT THERE WAS LIQUID IN THE PACKING FOR ONE (1) TI CANNULATED TIBIAL NAIL AND ONE (1) 11MM/125 DEG TI CANN TFNA 170MM - STERILE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10449871 ↗

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-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
• 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