TFN-ADVANCE 04.037.127SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982096418), received between Apr 5, 2021 and Jul 11, 2023 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Break; Break

  DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AN UNKNOWN TFNA NAIL BROKE POST OP. A THICKER NAIL WAS ORDERED AND A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - NAIL: TFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17298768 ↗
• InjurySep 24, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A REMOVAL SURGERY OF TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL DUE TO CRACKED AT LAG SCREW/ NAIL JUNCTION AND TRANSITION TO TOTAL HIP ARTHROPLASTY. ALL TFNA IMPLANTS WERE REMOVED. THE PATIENT WAS THAN REVISED TO A TOTAL HIP ARTHROPLASTY. THE ORIGINAL DATE OF THE SURGERY WAS ON (B)(6) 2020. CONCOMITANT DEVICE REPORTED: FEMORAL NECK SCREWS, PERFORATED, STERILE (PART: 04.038.205S; LOT: 12L5293; QUANTITY:1), LOCKING SCREWS (PART: 04.005.526; LOT: UNKNOWN; QUANTITY: 1), LOCKING SCREW (PART: 04.005.528S; LOT: UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TFNA 360MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12529210 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF DISTAL LOCKING SCREW AND TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL DUE TO BREAKAGE. THE INITIAL CITATION OF THE DEVICE WAS ONE YEAR AGO ON (B)(6) 2020. (B)(6) OF THIS YEAR, THE HELICAL BLADE WAS REMOVED, IT WAS ALSO REPORTED THAT THE PATIENT FELL AND HAD A NECK AND LOCKING SCREW BREAKAGE. TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL WHICH REMOVED AS WELL AS BROKEN LOCKING SCREW, CONVERSION TO A TOTAL HIP ARTHROPLASTY FOLLOWING REMOVAL OF HELICAL BLADE AND SUBSEQUENT FALL WHICH RESULTED IN A DISPLACED FEMORAL NECK FRACTURE. APPROXIMATELY 6 WEEKS AFTER HELICAL BLADE WAS REMOVED, PATIENT FELL AND SUFFERED A DISPLACED FEMORAL NECK FRACTURE WHICH LEAD TO THE TFNA REMOVAL AND CONVERSION TO A TOTAL HIP ARTHROPLASTY. PATIENT HAD THREE (3) SURGERIES, IMPLANTATION OF TFNA LONG NAIL ON (B)(6) 2020. REMOVAL OF HELICAL BLADE BECAUSE OF PAIN AT BLADE SITE ON LATERAL CORTEX OF FEMUR IN (B)(6) 2021. CONVERSION TO A TOTAL HIP ARTHROPLASTY FOLLOWS A FEMORAL NECK FRACTURE. THIS IS WHEN BROKEN DISTAL 5.0MM LOCKING SCREW WAS DISCOVERED. BROKEN DISTAL LOCKING SCREW AND NAIL WERE REMOVED SUCCESSFULLY. THIS (B)(4) CAPTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615993 ↗

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-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-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