TFN-ADVANCE 04.037.059SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982096159), received between Dec 21, 2018 and Aug 4, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2023, THE LIVE SCREW MISSED THE NAIL WHILE THE NAIL WAS PUT IN. SO, THEY HAD TO REMOVE IT AND REMOVE THE NAIL. IN REFERRING THE NEW NAIL AND OTHER OCCURRED LINED UP CORRECTLY. THIS REPORT IS FOR ONE (1)10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461803 ↗
• InjuryApr 13, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TFNA HARDWARE WAS REVISED DUE TO NAIL BREAKAGE. PATIENT WAS REVISED TO NEW HARDWARE. ORIGINAL IMPLANT DATE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY# UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 16734732 ↗
• InjuryJul 16, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021 PATIENT UNDERWENT REMOVAL OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM TFNA (TFNA) NAIL. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2021. THERE WAS PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN NAIL DISTAL LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)10/130 DEG TI CANN TFNA 380/LEFT - SILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

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

  MAUDE report 12185235 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A LAG SCREW IN NEED OF REPLACEMENT WITH A SHORT LAG SCREW. IT WAS FOUND THAT THE NAIL WAS BROKEN AT THE LEVEL OF THE LAG SCREW. THE NAIL WAS REMOVED AND THE NAIL, LAG SCREW AND LOCKING SCREW WERE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304421 ↗
• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION OPERATION FOR A BROKEN TROCHANTERIC FIXATION NAIL ADVANCES (TFNA) NAIL. THE PATIENT HAD A NON UNION THAT DID NOT HEAL. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2020. CONCOMITANT DEVICES: UNKNOWN TFNA HELICAL BLADE PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1; UNKNOWN LOCKING SCREWS PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11108158 ↗
• InjuryJan 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF A BROKEN TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF HIP IN (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY UNKNOWN), UNKNOWN HELICAL BLADE (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9555543 ↗
• InjuryDec 21, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2018. THE DEVICES REMOVED WERE A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, UNKNOWN HELICAL BLADE, AND TWO (2) UNKNOWN LOCKING SCREWS. IT WAS STATED THAT APPROXIMATELY 4 DAYS PRIOR TO THE EVENT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PROGRESSING LATERAL HIP PAIN. X-RAYS REVEALED A BROKEN TFNA NAIL AT THE BLADE NAIL JUNCTION. THE PATIENT'S ORIGINAL IMPLANT PROCEDURE WAS DONE ON (B)(6) 2018 DUE TO SUBTROCHANTERIC FRACTURE. THE FRACTURE WAS REPAIRED USING A SYNTHES PROXIMAL FEMUR PLATE AND SCREWS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8188637 ↗

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-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