TFN-ADVANCE 04.037.213SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982097033), received between Aug 27, 2021 and Jul 12, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

8 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.

Recalls naming this device

1. Feb 1, 2023Class IIOpen, Classified

   TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

   Z-1246-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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 12, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2022, THAT THE HELICAL BLADE OF TFNA WAS OVER INSERTED TOWARD MEDIAL SIDE. SO LATERAL SURFACE OF THE HELICAL BLADE WAS NOT FIXED FLAT WITH FEMUR LATERAL CORTEX. THERE NO PROBLEMS THAT IMPLANT LENGTH OR PROCEDURE DURING OPERATION. BUT WHEN WE CHECKED NAIL INSERTION STATUS BY C-RAM AFTER REMOVED INSTRUMENT, LATERAL SURFACE OF THE HELICAL BLADE WAS CHECKED THAT IT SANK RATHER THAN FEMUR LATERAL CORTEX. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) TFNA FEM NAIL 12 125 L200 TI. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14989713 ↗
• MalfunctionJun 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 OPEN REDUCTION AND INTERNAL FIXATION (ORIF) RIGHT FEMUR FRACTURE PROCURE WAS PERFORMED. IT WAS NOTED THAT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE TFNA FEM NAIL 12 125 L200 TI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678558 ↗
• InjuryAug 27, 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 ON JUNE, THE PATIENT UNDERWENT THE SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR WITH THE TFNA NAIL. ON JULY 30, THE PATIENT HAD A RE-FRACTURE WHEN HE TRIED TO MASSAGE HIS THIGH TO REMOVE SWELLING. HE HAS SEQUELAE OF SPINAL INJURY AND CANNOT MOVE LOWER EXTREMITIES. ON AUGUST 2, THE REVISION SURGERY WILL BE PERFORMED REMOVING THE IMPLANTS AND USING A LONGER NAIL AND CEMENT. THIS REPORT IS FOR ONE (1) 12MM/125 DEG TI CANN TFNA 200MM - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Swelling/ Edema

  MAUDE report 12379855 ↗

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-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-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-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