TFN-ADVANCE 04.037.057SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982096135), received between Aug 27, 2018 and Jul 7, 2025 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Break; Break

  IT WAS REPORTED THAT THE TFNA NAIL WAS BROKEN POSTOPERATIVELY. THE SURGEON REMOVED THE NAIL SUCCESSFULLY AND IMPLANTED A TOTAL HIP REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412942 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A BROKEN IMPLANT FAILURE. A NON-UNION OCCURRED AFTER 8 MONTHS WITH TFNA. THE NAIL WAS REPORTED TO HAVE BROKEN AT THE JUNCTURE OF THE HELICAL BLADE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 360MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17914754 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED A TFNA NAIL AND REVISED WITH ANOTHER TFNA NAIL DUE TO NON-UNION AND POSSIBLE INFECTION. THE SURGEON HAD DIFFICULTIES CONNECTING THE NAIL EXTRACTOR LIKELY DUE TO THE SET SCREW BEING TOO FAR BACK, TOO MUCH SOFT TISSUE INSIDE OF THE NAIL, BLOCKED BY OTHER STRUCTURES FROM BEING COLLINEAR TO ALLOW THE EXTRACTOR TO CONNECT. THE SURGEON CONNECTED THE AIMING ARM FOR EXTRACTION AND IT WAS SUCCESSFULLY REMOVED. THE EXTRACTOR WAS CHECKED POSTOPERATIVELY AND IT DID SUCCESSFULLY CONNECT TO THE NAIL. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS RELATED TO (B)(4). (B)(4): REPORTS THE DEVICE MALFUNCTION THAT OCCURRED DURING EXTRACTION SURGERY. (B)(4): REPORTS POSTOPERATIVE ADVERSE EVENTS AND IMPLANT REMOVAL. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 16767766 ↗
• MalfunctionApr 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED A TFNA NAIL AND REVISED WITH ANOTHER TFNA NAIL. THE SURGEON HAD DIFFICULTIES CONNECTING THE NAIL EXTRACTOR LIKELY DUE TO THE SET SCREW BEING TOO FAR BACK, TOO MUCH SOFT TISSUE INSIDE OF NAIL, BLOCKED BY OTHER STRUCTURES FROM BEING COLLINEAR TO ALLOW EXTRACTOR TO CONNECT. THE SURGEON CONNECTED THE AIMING ARM FOR EXTRACTION AND IT WAS SUCCESSFULLY REMOVED. THE EXTRACTOR WAS CHECKED POST OPERATIVELY AND IT DID SUCCESSFULLY CONNECT TO THE NAIL, THEREFORE, IT WAS LIKELY BLOCKED BY OTHER STRUCTURES. CURRENTLY, THERE IS NO PLAN TO RETURN THE EXTRACTOR UNLESS NEEDED. THERE WAS A SURGICAL DELAY OF 5 MIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE PATIENT CONSEQUENCES/OUTCOMES. THIS REPORT IS FOR ONE (1)10/130 DEG TI CANN TFNA 360/LEFT - SILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736772 ↗
• InjuryDec 21, 2022Break; Break

  THE NAIL WAS IMPLANTED IN (B)(6) 2022. THE NAIL WAS DISCOVERED TO BE BROKEN IN (B)(6) 2022. THE NAIL WAS BROKEN AT THE APERTURE. THE DISTAL LOCKING SCREW WAS INTACT. THE NAIL WAS REMOVED, AND THE PATIENT¿S FRACTURE WAS REVISED USING A 95 DEGREE BLADE PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16025734 ↗
• MalfunctionNov 7, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE SURGERY, WHILE DOING A TFNA, THE SURGEON COMMENTED THAT THE NAIL WAS VERY PROMINENT. THE PATIENT ALSO SEEMED TO HAVE A SMALL TROCHANTER AND THE SURGEON LIKE TO HAVE A 125 ANGLE TFNA. THERE WAS NO SURGICAL DELAY NOTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES NOTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 10/130 DEG TI CANN TFNA 360/LEFT - SILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759744 ↗
• InjuryOct 5, 2020Break; Break

  IT WAS REPORTED THAT ON(B)(6) 2020, THE SURGEON WAS REMOVING BROKEN/FAILED HARDWARE FROM THE PATIENT AND WAS CONVERTING TO A TOTAL HIP REPLACEMENT. THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL WAS BROKEN IN TWO (2) PIECES. THE LAG SCREW AND TWO (2) DISTAL LOCKING SCREWS WERE NOT BROKEN. ALL PIECES WERE REMOVED SUCCESSFULLY. FRAGMENTS WERE NOT GENERATED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW 90MM - STERILE (PART# 04.038.190S, LOT# H713641, QUANTITY# 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS (PART# 04.005.534, LOT# UNKNOWN, QUANTITY# 2). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10627599 ↗
• InjuryJun 18, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS TREATED FOR A FEMORAL NECK ¿STRESS FRACTURE¿ WITH 6.5 CANNULATED SCREWS. TWO DAYS LATER, PATIENT EXPERIENCED A FALL AND SUFFERED A PROXIMAL FEMUR FRACTURE. THE CANNULATED SCREWS WERE REMOVED AND A TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS IMPLANTED WITH A HELICAL BLADE. PATIENT RESUMED NORMAL ACTIVITY FOR 117 DAYS AT WHICH POINT THEY EXPERIENCED ANOTHER PROXIMAL FEMUR FRACTURE AFTER THE TFNA NAIL BROKE AT THE NAIL/BLADE JUNCTION. IT IS UNKNOWN IF THE PATIENT UNDERWENT A REVISION/REMOVAL PROCEDURE. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: 04.038.380S, LOT: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 10MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10169470 ↗
• InjuryNov 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON MEASURED NAIL LENGTH AND ENDED UP APPEARING TO PROTRUDE INTO THE KNEE JOINT WHEN EXAMINING UNDER FLUOROSCOPY. THE SURGEON DID NOT ELECT TO REMOVE NAIL AND EXCHANGE FOR A SHORTER NAIL. THE SURGEON ANTICIPATES THAT THE LOCATION OF THE PROTRUSION IN THE KNEE WILL NOT BOTHER THE PATIENT AND DECIDED TO LEAVE THE NAIL. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE OF DISTAL END OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) PROTRUDING INTO KNEE JOINT SPACE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: Injury

  MAUDE report 9311751 ↗
• InjurySep 17, 2018Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) NAIL, ONE (1) HELICAL BLADE, AND TWO (2) DISTAL LOCKING SCREWS. THE PATIENT WAS IMPLANTED WITH THE TFNA NAIL, BLADE AND LOCKING SCREWS ON AN UNKNOWN DATE. SUBSEQUENTLY, IT WAS NOTICED THAT THE NAIL WAS BROKEN AT THE PROXIMAL END OF THE DISTAL LOCKING SCREWS. APART FROM THIS, IT WAS NOTED THAT THERE WAS A NON-UNION AND FEMUR FRACTURE. WHEN THE PATIENT RETURNED TO THE OPERATING ROOM, THE NAIL WAS EXPLANTED WITHOUT INCIDENT AND AN EXTERNAL FIXATION DEVICE WAS PLACED TO CLEAR THE INFECTION. PATIENT OR SURGICAL OUTCOME WERE NOT PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing; Unspecified Infection

  MAUDE report 7880951 ↗
• InjuryAug 27, 2018Break; Break

  THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7819219 ↗

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