TFN-ADVANCE 04.038.095SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982098498), received between May 2, 2018 and Jul 29, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2022Migration; Migration

  ON (B)(6) 2020 PATIENT HAD UNDERGONE REVISION OF TFNA DUE TO LEFT INTERTROCHANTERIC FEMUR FRACTURE WITH IMPENDING NON-UNION AND LEFT FEMORAL HEAD, CUT-OUT ALSO/FRACTURE FEMORAL HEAD. IT WAS REPORTED THE PATIENT HAD WORSENING PAIN WITH COLLAPSE OF HER INTERTROCHANTERIC FEMUR FRACTURE IN AN UNCONTROLLED MANNER. IT APPEARED THAT LAG SCREW HAD SPUN WITHIN THE NAIL AND FRACTURED. THIS REPORT INVOLVES ONE (1) TFNA SCREW 95MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS PRODUCT COMPLAINT (B)(4), IS RELATED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15131113 ↗
• InjuryDec 30, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A PROCEDURE. IT WAS NOTED THAT THE TFNA SHORT NAIL BROKE AT PROXIMAL END OF THE NAIL. THE NAIL FRACTURED AT THE CEPHALOMEDULLARY TFNA SCREW OPENING. IT IS UNKNOWN IF THE PROCEDURE COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TFNA SCREW 95MM - STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

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

  MAUDE report 13120187 ↗
• InjuryMay 1, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL/ REVISION OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PATIENT PRESENTED WITH FOLLOW UP X-RAYS THAT SHOWED THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) TITANIUM SCREW BACKED UP AND THE FEMORAL HEAD ROTATED. DURING REVISION, IT WAS FOUND THAT THE LOCKING GATE WAS BROKEN INSIDE THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) SHORT NAIL BROKE. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE BUT EVERYTHING WAS REMOVED WITHOUT A PROBLEM. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT'S OUTCOME WAS A STABLE REVISION CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1); UNKNOWN END CAP: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS ONE (1) TFNA SCREW 95MM - STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10018229 ↗
• InjurySep 6, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2018, DUE TO A SUBTROCHANTERIC FRACTURE AND NON-UNION. THE PATIENT HAD A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) TITANIUM LAG SCREW AND A DISTAL LOCKING SCREW PREVIOUSLY IMPLANTED ON AN UNKNOWN DATE. A BROKEN TFNA LONG NAIL AND A BROKEN TITANIUM LAG SCREW WERE REPLACED WITH AN UNKNOWN BLADE PLATE. ALL HARDWARE WAS REMOVED SUCCESSFULLY WITHOUT ANY ISSUES. CONCOMITANT DEVICE REPORTED: DISTAL LOCKING SCREW (PART NUMBER 04.005.436, LOT UNKNOWN, QUANTITY OF 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 7851913 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) WHICH INCLUDES ONE (1) 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE, ONE (1) TFNA SCREW 95MM - STERILE AND ONE (1) 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS-STERILE. ON AN UNKNOWN DATE POST-OPERATIVE, THE FEMORAL NECK COLLAPSED CAUSING THE PATIENT DISCOMFORT. ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION IN THE FRACTURE SITE. THE ENTIRE IMPLANT WAS REMOVED AND REPLACED WITH A TOTAL HIP ARTHROPLASTY. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TFNA SCREW 95MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7642261 ↗
• InjuryMay 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, TFNA SCREW, AND 5.0MM LOCKING SCREW ON UNKNOWN DATE IN 2017. ON UNKNOWN DATE IT WAS REVEALED THE TFNA SCREW HAD CUT THROUGH THE LATERAL CORTEX OF THE FEMUR AS A RESULT OF A NON-UNION. THE CUT THROUGH RESULTED IN IRRITATION OF SOFT TISSUE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT WAS REVISED TO A TOTAL HIP CONSTRUCT. THIS REPORT IS FOR ONE (1) TFNA SCREW 95MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7480970 ↗

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-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