TFN-ADVANCE 04.037.461SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982097651), received between Aug 16, 2019 and Feb 10, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT POSTOPERATIVELY, IT WAS OBSERVED THAT A TFNA NAIL AND DISTAL LOCKING SCREW HAD BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 21349421 ↗
• MalfunctionMar 27, 2024Material Discolored; Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component; Material Twisted/Bent; Material Discolored; Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANTS IN QUESTION WERE DAMAGED. THE BOXES THAT CONTAINED THE ITEMS HAD GOTTEN WET, CAUSED THE BOXES TO DISCOLOR AND FALL APART. THE INSTRUMENTS WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 14MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985409 ↗
• InjuryAug 1, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT CAME TO ER STATING THAT SHE HAD A GROUND LEVEL FALL AND WAS COMPLAINING OF INCREASE LEFT HIP PAIN. PATIENT HAD ORIGINAL TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) IMPLANTED ON (B)(6) 2022. SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR REMOVAL OF BROKEN HARDWARE WHICH WAS CONFIRMED BY ER X-RAYS ON (B)(6) 2022. HARDWARE WAS REMOVED AND A TROCHANTERIC FIXATION NAI (TFN) WAS CHOSEN FOR THE REPAIR BECAUSE THE TFN HAD A LARGER DIAMETER PROXIMAL BODY AND LAG SCREW. IMPLANTS WERE REMOVED AND DOCUMENTED AND TFN WAS IMPLANTED WITH SUCCESS. IT WAS DESCRIBED THAT IMPLANT FAILED AT PROXIMAL END OF NAIL, PROXIMAL TO LAG SCREW INSERTION HOLE. PATIENT EXPERIENCED AN ADVERSE EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 14MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15140420 ↗
• InjuryNov 3, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A PROCEDURE 14/130 DEG TI CANN TFNA 400/LEFT-STERILE BROKE INTO TFNA NAIL. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 14/130 DEG TI CANN TFNA 400/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12746157 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LEFT NAIL 14 X 400MM, 110MM FENESTRATED SCREW, AND TWO (2) DISTAL INTER-LOCKING SCREWS WERE REMOVED DUE TO BONE NON-UNION. PATIENT HAS CANCER. DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. IMPLANTS WERE REMOVED SUCCESSFULLY WITHOUT COMPLICATIONS. THIS REPORT IS FOR ONE (1) 14MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11100556 ↗
• InjurySep 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF A BROKEN TFNA HIP NAIL THAT BROKE INSIDE THE PATIENT. THE PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 14MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10516466 ↗
• InjuryAug 16, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: TFNA FENESTRATED HELICAL BLADE (PART: 04.038.410 LOT: H54340, QUANTITY: 1), TITANIUM (TI) LOCKING SCREW (PART: 04.005.536, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 14MM/130 DEGREE TI CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8901052 ↗

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-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