TFN-ADVANCE 04.037.143SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982096555), received between Jan 27, 2021 and Sep 1, 2026 — classified as 3 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Break

  It was reported during a nail change in the case of a peri-implant femur fracture, it was found that the nail to be replaced had broken through the hole of the femoral neck blade/screw. The nail was implanted on (b)(6) 2025 ,Revision occurred (b)(6) 2026.

  Patient problems: Limb Fracture

  MAUDE report 50547220 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS NOT POSSIBLE TO UNLOCK THE SYSTEM TO REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 24168353 ↗
• InjuryJan 15, 2026Device-Device Incompatibility

  PERTROCHANTERIC FRACTURE OF THE RIGHT FEMUR ON (B)(6) 2024. PATIENT EXPERIENCED LAMENESS AND DISCOMFORT. EXAMINATION SHOWED AN ANTERIOR HIP ELEVATION. RADIOGRAPHS FOUND MATERIAL IN PLACE WITH DEFINITIVE CONSOLIDATION BUT RESULTING FROM NAIL AND SCREW. AFTER DISCUSSION WITH THE PATIENT OF THE DIFFERENT OPTIONS IT WAS AGREED TO PERFORM AN EXCISION OF THE RIGHT HIP MATERIAL. ATTEMPTED TO REMOVE THE EQUIPMENT (B)(6) 2025, ENDED IN A FAILURE: IMPOSSIBLE TO UNLOCK THE SYSTEM. NO POSSIBILITY TO DO SO FROM NOW ON, ACCORDING TO THE SURGEON, BECAUSE THE SYSTEM IS DISTORTED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 24079761 ↗
• MalfunctionDec 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SURGEON EXPERIENCED DIFFICULTY TIGHTENING THE LOCKING MECHANISM ONTO THE BLADE SURFACE. THE STATIS LOCKING SCREWDRIVER ASSEMBLY WAS PASSED THROUGH THE INSERTION HANDLE, BUT IT WAS UNCERTAIN WHETHER IT HAD FULLY ENGAGED THROUGH THE CANNULATED CONNECTING SCREW. THE SURGEON SUSPECTED IT WAS NOT PROPERLY SEATED IN THE HEXAGONAL RECESS OF THE LOCK DRIVE, AS CLOCKWISE ADVANCEMENT WAS NOT POSSIBLE. MULTIPLE ATTEMPTS WERE MADE USING BOTH THE FLEXIBLE SCREWDRIVER (03.037.028) AND THE 5 MM HEXAGONAL SCREWDRIVER SHAFT (03.027.029), BUT WITHOUT SUCCESS. THE SURGEON THEN ATTEMPTED A FEW LIGHT MALLET TAPS TO HELP ENGAGE THE LOCK DRIVE, WHICH ALSO FAILED. THE SURGEON DECIDED TO REMOVE THE NAIL FOR INSPECTION. HOWEVER, WHEN ATTEMPTING TO DETACH THE HEXAGONAL SCREWDRIVER SHAFT, IT COULD NOT BE DISCONNECTED FROM THE INSERTION HANDLE. AS A RESULT, THE ENTIRE CONSTRUCT (HEXAGONAL SCREWDRIVER SHAFT, INSERTION HANDLE, AND NAIL) HAD TO BE REMOVED AS ONE PIECE. THE SURGEON PROCEEDED WITH A SECOND INSTRUMENT SET AND A NEW NAIL. USING THE SAME STEPS, THE SURGEON WAS ABLE TO ADVANCE THE LOCKING MECHANISM SUCCESSFULLY WITH THE 5 MM FLEXIBLE SCREWDRIVER PASSED THROUGH THE CONNECTING SCREW A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887276 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALSO REPORTED THAT THE PATIENT WAS CONVERTED TO TOTAL HIP PROSTHESIS DUE TO NONUNION AFTER 6 MONTHS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11237659 ↗

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-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-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-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