TFN-ADVANCE 04.037.158SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982096661), received between Jun 27, 2018 and Dec 1, 2025 — classified as 10 injuries, 2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THE PATIENT FELL AND THE NAIL BROKE.

  Patient problems: Fall

  MAUDE report 23682992 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2023 DURING A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) PROCEDURE, THE NAIL COULD NOT BE RELEASED FROM INSERTION HANDLE. SURGEON HAD TO REMOVE THE HELICAL BLADE AND NAIL AND RELOAD A DIFFERENT NAIL. THERE WAS SURGICAL DELAY OF APPROXIMATELY TWENTY (20) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THE PATIENT WAS NOT HARMED. THIS REPORT IS FOR ONE (1) 11/130 DEG TI CANN TFNA 380/RIGHT - SILE THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396827 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT CAME FOR REMOVAL OF TFNA AND WAS GIVEN A TOTAL HIP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15122569 ↗
• InjuryMar 20, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA); IT WAS NOTED THE NAIL FAILED BECAUSE OF NON-UNION (B)(6). THE BROKEN NAIL WAS REMOVED SUCCESSFULLY. THIS REPORT IS FOR A TFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13835292 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THERE WAS A SUBTROCHANTERIC NON-UNION ON A RIGHT FEMUR FRACTURE. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL WAS BROKEN AND WOULD BE REMOVED AND REPLACED WITH A NEW NAIL. THE PROCEDURE TO REMOVE THE BROKEN NAIL WENT AS PLANNED, HOWEVER THE HELICAL BLADE COUPLING SCREW WAS DAMAGED DURING THE REMOVAL OF THE HARDWARE. CONCOMITANT DEVICES: UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN); UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12770709 ↗
• InjuryDec 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL, TITANIUM HELICAL BLADE, AND A LOCKING SCREW DUE TO IMPROPER INSERTION OF TITANIUM HELICAL BLADE ON INITIAL SURGERY. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10950506 ↗
• InjuryAug 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); TFNA FENESTRATED HELICAL BLADE 90MM - STERILE (PART # 04.038.390S, LOT # 13L5990, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 10442148 ↗
• InjuryJul 9, 2020Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT SHOW UP IN OFFICE COMPLAINING OF HIP PAIN AND THE X-RAY SHOWED A BROKEN TFNA NAIL AND UNDERWENT REMOVAL AND A TOTAL HIP ARTHROPLASTY WAS PERFORMED. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA SCREW (PART # 04.038.085S, LOT # UNKNOWN, QUANTITY 1). UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10254367 ↗
• InjuryMay 13, 2020Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Unspecified Infection

  MAUDE report 10053636 ↗
• InjuryMay 16, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) DUE TO NON-UNION AND DELAYED HEALING. TFNA NAIL, THE HELICAL BLADE, AND LOCKING SCREW WERE REMOVED EASILY. THE NAIL BROKE AT THE BLADE/SCREW INTERFACE. A NEW TROCHANTERIC FIXATION NAIL (TFN) AND TFN SCREW WERE PUT IN PLACE. CEMENT AUGMENTATION WAS ALSO USED; A DISTAL LOCKING SCREW WAS PLACED. INITIAL SURGERY TOOK PLACE (B)(6) 2018. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS REMAINED IN GOOD HEALTH. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS (PART 04.005.534, LOT UNKNOWN, QUANTITY 3) TFNA HELICAL BLADE 100MM (PART 04.038.300, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8617268 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL DUE TO A BROKEN TFNA NAIL AS WELL AS NON-UNION. THE NAIL WAS BROKEN AT THE LAG SCREW JUNCTION. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: TFNA FENESTRATED SCREW 100MM ¿ STERILE (PART: 04.038.200S, LOT: UNKNOWN, QUANTITY: 1) . THIS REPORT IS FOR A 11MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA 380MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7842086 ↗
• InjuryJun 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT REVISION OF PROXIMAL FEMORAL NAILING SYSTEM ADVANCED (TFNA) AND PROXIMAL FEMORAL HOOK PLATE DUE TO NON UNION AND DELAYED HEALING. FAILURE OF DEVICE WAS DETECTED THROUGH X-RAY. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: TFNA SCREW PERFORATED (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7642461 ↗

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-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-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-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