TFN-ADVANCE 04.037.261SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982097415), received between Aug 30, 2018 and Nov 20, 2025 — classified as 8 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SAME PATIENT HAS EXPERIENCED 3 TFNA NAILS BREAKING IN THE SAME AREA OF THE NAIL, RESULTING IN A FINAL NAIL REMOVAL AND PROXIMAL FEMUR REPLACEMENT. THE NAIL WAS EXAMINED UPON REMOVAL AND DIDN¿T SEEM TO HAVE ANY SIGNS OF DRILL DAMAGE FROM INITIAL NAIL PLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23603750 ↗
• InjuryNov 19, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SAME PATIENT HAS EXPERIENCED 3 TFNA NAILS BREAKING IN THE SAME AREA OF THE NAIL, RESULTING IN A FINAL NAIL REMOVAL AND PROXIMAL FEMUR REPLACEMENT. THE NAIL WAS EXAMINED UPON REMOVAL AND DIDN¿T SEEM TO HAVE ANY SIGNS OF DRILL DAMAGE FROM INITIAL NAIL PLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23592605 ↗
• InjuryNov 13, 2025Break; Break

  IT WAS REPORTED THAT THE SAME PATIENT HAS EXPERIENCED 3 TFNA NAILS BREAKING IN THE SAME AREA OF THE NAIL, RESULTING IN A FINAL NAIL REMOVAL AND PROXIMAL FEMUR REPLACEMENT. THE NAIL WAS EXAMINED UPON REMOVAL AND DIDN¿T SEEM TO HAVE ANY SIGNS OF DRILL DAMAGE FROM INITIAL NAIL PLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23541553 ↗
• InjuryAug 20, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEMUR NON-UNION WITH BROKEN TFNA AND SCREWS. IMPLANTS WERE REMOVED AND REPLACED WITH NEW TFNA.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22848809 ↗
• MalfunctionDec 9, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, WHEN SURGEON WAS ADVANCING THE SET SCREW IN THE PROXIMAL PORTION OF THE NAIL, IT WOULD NOT ADVANCE DISTAL ENOUGH WITHIN THE NAIL TO ENGAGE WITH THE TFNA LAG SCREW. IT SEEMED LIKE IT WAS NOT CENTERED PROPERLY WITHIN THE NAIL OR WAS CROSS THREADED. AFTER TURNING THE SET SCREW COUNTER CLOCKWISE AND HAMMERING ON THE 5.0MM FLEXIBLE SCREWDRIVER SEVERAL TIMES THE SET SCREW ADVANCED DISTAL ENOUGH TO ENGAGE WITH THE TFNA LAG SCREW IN THE STATIC POSITION. THIS DELAYED THE CASE FOR ABOUT FIFTEEN (15) MINUTES. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969631 ↗
• InjurySep 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN POSTOPERATIVE DATE THE TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL BROKE. THE PATIENT HAD A NON UNION OF THE LEFT. THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2021 TO REMOVE THE BROKEN NAIL AND REPLACE IT WITH A LARGER NAIL. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12418073 ↗
• InjuryJan 4, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT A REVISION OPERATION DUE TO A BROKEN LONG 400MM TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). THE BREAK OCCURRED APPROXIMATELY SIX (6) MONTHS AFTER IMPLANTATION NEAR THE PROXIMAL BOD AT THE HELICAL BLADE OPENING. THE IMPLANT WAS REPLACED WITH AN ADDITIONAL TFNA IMPLANT WITH A SCREW INSTEAD OF A HELICAL BLADE. THE SURGERY WAS REVISED TO REMOVE AND REPLACE THE FAILED IMPLANT. CONCOMITANT DEVICES: UNK - END CAPS: TFNA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNK - SCREWS: LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11108620 ↗
• InjuryJul 31, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION OSTEOTOMY SURGERY DURING WHICH THE FAILED AND FRACTURED HARDWARE WAS REMOVED AND REPLACED WITH NEW HARDWARE. ON (B)(6) 2016, THE PATIENT UNDERWENT AN INTRAMEDULLARY NAILING SURGICAL PROCEDURE AFTER SUSTAINING A LEFT SUBTROCHANTERIC FEMUR FRACTURE. ON OR ABOUT (B)(6) 2017, THE PATIENT INFORMED THAT THE HARDWARE HAD FAILED AND THAT ITS CANNULATED TITANIUM NAIL HAD FRACTURED. CONCOMITANT DEVICES REPORTED: TFNA 105MM HELICAL BLADE (PART# 04.038.305S, LOT# 7971267, QUANTITY (B)(4)), 5X48MM INTERLOCKING SCREW (PART# UNKNOWN, LOT# 651785, QUANTITY (B)(4)).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10353001 ↗
• InjuryAug 30, 2018Crack; Crack

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. ORIGINAL IMPLANT DATE WAS (B)(6) 2018 AND PATIENT OUTCOME POST-SURGERY WAS UNEVENTFUL. THE PATIENT REPORTED INCREASING PAIN AND A CRACK WAS IDENTIFIED IN THE TFNA NAIL AT THE PROXIMAL SCREW HOLE ON AN UNKNOWN DATE. THERE WERE INDICATIONS THAT THERE WAS FURTHER TRAUMA THAT MIGHT HAVE LED TO THE NAIL FRACTURE. THE NAIL WAS REMOVED, AND THE FRACTURE WAS FIXED WITH BLADE PLATE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY AND IF THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 12MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7832417 ↗

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-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