TFN-ADVANCE 04.038.315SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982099099), received between Jun 13, 2018 and Mar 15, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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.

• MalfunctionMar 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE THE SURGEON WAS IMPLANTING PROXIMAL FEMORAL NAILING SYSTEM (TFNA), WHEN TRYING TO DRIVE THE UNKNOWN HELICAL BLADE TO THE TFNA NAIL, IT DID NOT ADVANCE AND PASS THE TFNA NAIL. THE SURGEON COULD NOT BACK OFF THE SET SCREW OR GET THE INSERTION HANDLE OFF WITH THE NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485892 ↗
• MalfunctionFeb 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2021, THE HELICAL BLADE WAS NOT ADVANCING COMPLETELY THROUGH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SHORT NAIL 170MM AND WAS NOT ABLE TO BE EXTRACTED EASILY. HARDWARE WAS ABLE TO BE COMPLETELY REMOVED AND NEW HARDWARE WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TFNA HELICAL BLADE 115MM STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274695 ↗
• InjuryJun 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL SYSTEM ADVANCE (TFNA). THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2018 DUE TO DISCOMFORT FROM LATERAL CUT OUT FROM THE HELICAL BLADE. THE FEMORAL NECK COLLAPSED, FORCING THE BLADE TO PROTRUDE LATERALLY. THE ENTIRE IMPLANT WAS REMOVED AND REVISED TO A TOTAL HIP ARTHROPLASTY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. CURRENT PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: 11MM/130 DEG TITANIUM CANNULATED TFNA NAIL - STERILE (PART: 04.037.142S, LOT: H059183, QUANTITY: 1), DISTAL LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A TFNA HELICAL BLADE 115MM STERILE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 7596628 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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-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-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