TFN-ADVANCE 04.037.265SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982097453), received between Apr 23, 2021 and Jan 23, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT HAD A REVISION SURGERY TODAY FOR A HIP FRACTURE USING IMPLANT SYNTHES TFNA BROKE, SURGEON HAD TO REVISE IT AND SURGEON TOLD TO SALES REP THAT NOTICE SOME SIGNS MAYBE 6 MONTHS AGO LOOKS LIKE THAT PATIENT WILL HEAL BUT WAS NOT HEAL REQUIRED REVISION SURGERY. NO SURGICAL DELAY IN THE REMOVAL PROCESS. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: AFTER SURGERY, THEY WERE SENT OUT FOR THE TYPICAL REHABILITATION PROCESS. THIS REPORT IS FOR ONE (1) 12/130 DEG TI CANN TFNA 440/LEFT-STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 18564295 ↗
• InjuryDec 7, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL AND THE OUTCOME WAS GOOD. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN NAIL DISTAL LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12/130 DEG TI CANN TFNA 440/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 12954317 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TFNA FENESTRATED HELICAL BLADE, TI CANNULATED TFNA NAIL, AND AN UNKNOWN SCREW WERE RECEIVED BROKEN. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENTS ARE REPORTED. THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR (1) 12MM/130 DEG TI CANN TFNA 440MM/LEFT-STERILE. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316144 ↗
• InjuryJun 28, 2021Break; Break

  IT WAS REPORTED THAT, A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS IMPLANTED A COUPLE OF MONTHS AGO. ON (B)(6) 2021, THE NAIL BROKE AND IT WAS REVIVED TO A TOTAL HIP AT (B)(6) MEDICAL CENTER. CONCOMITANT DEVICE REPORTED: UNK: NAIL HEAD ELEM: TFN HELICAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNK: SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) UNK, NAILS: TFNA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 12078958 ↗
• InjuryApr 23, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE NON-UNION, BROKEN NAIL. ON (B)(6) 2020, THIS PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF A SUB-TROCHANTERIC FEMUR FRACTURE. A LONG PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. SUBSEQUENTLY, THE FRACTURE WENT ON TO NON-UNION, AND THE TFNA NAIL BROKE AT THE HELICAL BLADE APERTURE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2021. TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW WERE REMOVED WITHOUT ANY DIFFICULTY AND A 95 DEGREE ANGLED BLADE PLATE WAS INSERTED. THE FRACTURE WAS REDUCED, AND COMPRESSED BY MEANS OF THE ARTICULATED TENSIONER DEVICE. NO SURGICAL DELAY HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) 12MM 130 DEGREE TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11718507 ↗

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-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-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-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