TFN-ADVANCE 04.037.043SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982095992), received between Nov 5, 2018 and Jun 22, 2026 — classified as 4 injuries, 5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A CUT-THROUGH OF THE HELIX BLADE, WITH BROKEN SET SCREW OF THE TFNA. THE PATIENT UNDERWENT REVISION SURGERY. IMPLANTS WERE DESTROYED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578627 ↗
• InjurySep 2, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A SHORT TFNA INSERTED THIS YEAR WITHIN THE LAST 6 MONTHS. ORIGINAL SURGEON WANTED TO INSERT LONG NAIL BUT PATIENT WAS UNWELL DUE TO ANAESTHETIC COMPLICATIONS AND NOT DUE TO FRACTURE RELATED. THEREFORE SURGEON WAS ASKED TO BE QUICK AND IF HE COULD INSERT A SHORT NAIL INSTEAD. PATIENT HAD A FALL AND FRACTURED AT THE DISTAL LOCKING SCREW OF NAIL POSTOPERATIVELY. THE SHORT TFNA WAS REMOVED AND LONG TFNA WAS INSERTED WITH TRAUMACEM. RIA2 WAS USED TO IRRIGATE AND HARVEST BONE GRAFT. PROXIMAL FEMUR PPFX PLATE USED TO SUPPLEMENT FIXATION.

  Patient problems: Fall

  MAUDE report 22948325 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A TFNA IMPLANTED ON THE (B)(6) 2024. THE TFNA SCREW WAS EXCHANGED ON THE (B)(6) 2025 DUE TO PAIN. SINCE THEN, THE FEMORAL NECK HAS COLLAPSED WITH SIGNIFICANT SHORTENING. THE TFNA IS NOW BEING REMOVED AND REVISED TO A HEMIARTHROPLASTY. THE SURGEON HAS ACKNOWLEDGED THIS IS NOT AN IMPLANT FAILURE, BUT A RESULT OF THE PATIENT¿S BONE PHYSIOLOGY.

  Patient problems: Necrosis; Physical Asymmetry

  MAUDE report 22199481 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE BLADE DIDN`T GO THROUGH THE NAIL. A NEW ONE WAS USED AND SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN OF SURGERY WAS DELAYED. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 10/130 DEG TI CANN TFNA 200 - STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278454 ↗
• InjuryJan 26, 2023Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NAIL IN QUESTION BROKE UNDERNEATH THE DISTAL LOCKING SCREW. PATIENT OUTCOME WAS NOT REPORTED. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 200MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16246316 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH THE TFNA IMPLANTS IN QUESTION. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PATIENT HAD A RECENT FALL AND EXPERIENCED PAIN. THE PATIENT EXPERIENCED DIFFICULTY WALKED AND PRESENTED TO THE HOSPITAL. X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED THE FEMORAL HEAD TO BE BROKEN. THE SURGEON DECIDED TO REMOVE THE TFNA IMPLANT AND PROCEED WITH REPLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REPLACEMENT SURGERY. THE IMPLANT WAS REMOVED AND THE PATIENT WAS PLANNED FOR BIPOLAR/ TOTAL HIP REPLACEMENT. HOWEVER, INFECTION WAS FOUND IN THE PATIENT AND THE REPLACEMENT PROCEDURE DID NOT PROCEED. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 200MM - STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12870551 ↗
• MalfunctionAug 13, 2021Break; Break

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TWO TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SETS THAT WERE SENT EACH HAD FAULTY DEMO NAILS. IN ONE SET, THE TFNA NAIL HAD A BROKEN LOCKING MECHANISM, AND ON THE OTHER THE NAIL¿S ALIGNMENT WAS OFF SUCH THAT THE BLADE WOULD NOT PASS THROUGH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 10MM/130 DEG TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318594 ↗
• MalfunctionAug 13, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TWO TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SETS THAT WERE SENT EACH HAD FAULTY DEMO NAILS. IN ONE SET, THE TFNA NAIL HAD A BROKEN LOCKING MECHANISM, AND ON THE OTHER THE NAIL¿S ALIGNMENT WAS OFF SUCH THAT THE BLADE WOULD NOT PASS THROUGH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 10MM/130 DEG TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318571 ↗
• MalfunctionNov 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) INSERTION ON (B)(6) 2018, THE DRILL BIT HIT THE TFNA NAIL WHILE DRILLING THE DISTAL HOLE. UNDER EXAMINATION OF THE PIECES WITH ANOTHER NAIL, THE GUIDE LINED UP AND THE DRILL WENT THROUGH WITHOUT CONTACT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: THREE FLUTED DRILL BIT (PART: 03.010.061S, LOT: H613995, QUANTITY: 1). CANNULATED CONNECTING SCREW (PART: 03.037.010, LOT: 7343556, QUANTITY: 1). 130 DEGREE AIMING ARM (PART: 03.037.013, LOT: UNKNOWN, QUANTITY: 1). COMPLETE RADIOLUCENT INSERTION HANDLE (PART: 03.037.012, LOT: L320306, QUANTITY: 1). PROTECTION SLEEVE (PART: 03.025.040, LOT: UNKNOWN, QUANTITY: 1). DRILL SLEEVE 200MM (PART: 03.010.065, LOT: L393576, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039226 ↗

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