TFN-ADVANCE 04.037.025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982095831), received between Aug 29, 2022 and Jan 12, 2023 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR SUBTROCHANTERIC FRACTURE WITH THE PRODUCTS IN QUESTION. THE PATIENT WAS A YOUNG MALE WITH GOOD BONE QUALITY. IT IS POSSIBLE THAT THE NAIL WAS SLIGHTLY SHAVED AND THE RESIDUAL IRON DEBRIS IN THE BODY, BECAUSE THE GUIDE PIN OF THE BLADE HAS BEEN INSERTED IN A SQUISHED POSITION AND WHEN REAMING THE BONE HEAD THE SQUISHED GUIDE PIN MAY HAVE MISLED CAUSING THE BONE HEAD REAMER TO INTERFERE WITH THE NAIL. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. POSTOPERATIVELY, THE GUIDE PIN AND OSTEOCLAVICULAR REAMER WERE CHECKED, AND SINCE THEY WERE NOT SHAVED, IT IS LIKELY THAT THE NAIL WAS SHAVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/125 DEG TI CANN TFNA 340MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150202 ↗
• InjuryAug 29, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY WITH THE NAIL IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE NAIL BREAKAGE WAS CONFIRMED ON (B)(6) 2022. THE FRACTURE SITE HAS GRADUAL BONE UNION, AND THE PATIENT HAS BEEN PRESCRIBED TERIPARATIDE (TERIBONE). THERE WAS AN OPINION THAT A TECHNIQUE FOR DYNAMIZATION SHOULD BE SELECTED, BUT THE SURGEON COMMENTED THAT IT COULD NOT BE HANDLED BECAUSE IT WAS STATIC FIXATION. A REVISION SURGERY WAS PLANNED FOR AND PERFORMED ON (B)(6) 2022, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/125 DEG TI CANN TFNA 340MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15311624 ↗

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-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-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