TFN-ADVANCE 04.037.155SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982096630), received between Sep 19, 2018 and Sep 3, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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.

• InjurySep 3, 2020Break; Break

  UPDATED CONCOMITANT DEVICES REPORTED: TFNA HELICAL BALDE (PART#: 04.038.395S, LOT#: 12L1987, QUANTITY: UNKNOWN); UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10488173 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE TOTAL HIP DUE TO AVASCULAR NECROSIS (AVN) OF FEMORAL HEAD ON (B)(6) 2019. THE LONG PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE WAS IN THE PATIENT'S PELVIS. THE DEVICE WAS NOT BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; No Code Available

  MAUDE report 8488178 ↗
• InjurySep 19, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A BROKEN TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) LONG NAIL AND DELAYED HEALING. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TFN-A NAIL, HELICAL BLADE, AND DISTAL LOCKING SCREW ON (B)(6) 2017. THE BROKEN TFNA NAIL WAS REMOVED SMOOTHLY AND DISPOSED OF. THE REVISION SURGERY WAS COMPLETED USING THE SAME SIZE TFN-A NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1), UNKNOWN DISTAL LOCKING SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7889279 ↗

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-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