TFN-ADVANCE 04.038.295SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982099013), received between Oct 9, 2018 and Jul 28, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 TFNA HELICAL BLADE 95MM STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15122573 ↗
• InjuryApr 19, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE DUE TO PATIENT COMPLAINED OF SYMPTOMATIC PAIN FROM HARDWARE FROM A PREVIOUS SURGERY. THE HELICAL BLADE FROM A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANT WAS PROTRUDING APPROXIMATELY 20MM OUTSIDE OF THE LATERAL CORTEX. THE PATIENT HAD GONE ON TO HEAL SO THE SURGEON DECIDED TO REMOVE THE HELICAL BLADE. THE HELICAL BLADE DESIGNED FOR DYNAMIC COLLAPSE. DURING THE PROCESS OF DYNAMIC COLLAPSE, THE BLADE WAS PROTRUDING TOO FAR FROM THE LATERAL CORTEX CREATING PAIN FOR THE PATIENT. THE HELICAL BLADE WAS THE ONLY IMPLANT THAT WAS REMOVED DURING THE REVISION SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 95MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 8531568 ↗
• InjuryMar 7, 2019Migration; Migration

  THE REVISION PROCEDURE OCCURRED ON (B)(6) 2019. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 8400231 ↗
• InjuryNov 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP SURGERY ON AN UNKNOWN DATE. A FRACTURE DISPLACED AFTER THE PROXIMAL FEMORAL NAILING SYSTEM TFN-ADVANCED (TFNA) HELICAL BLADE SLIDE MECHANISM RESULTED IN A MIGRATION EFFECT. SURGICAL AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 95MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8071072 ↗
• InjuryOct 29, 2018Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DURING HIP SURGERY. A FOLLOW UP X-RAY WAS DONE SHOWING THAT THE TFNA HELICAL BLADE HAD PERFORATED THE FEMORAL HEAD. REVISION SURGERY TO SHORTEN THE LENGTH OF THE TFNA HELICAL BLADE WAS PERFORMED ON (B)(6) 2018. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE: TFNA NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A TFNA HELICAL BLADE 95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8015576 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY OF THE HIP DUE TO IMPLANT FAILURE AND FAILURE TO HEAL. THE REASON FOR THE FAILURE TO HEAL IS UNKNOWN. THE FAILED IMPLANT INVOLVED TROCHANTERIC FEMORAL NAILING ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA- HELICAL BLADE, AND UNKNOWN LOCKING SCREWS WHICH WERE REMOVED AND REPLACED. THE SURGEON INSERTED A NEW TFNA NAIL AND TFNA-TITANIUM CANNULATED SCREW IN PLACE OF THE HELICAL BLADE. IT WAS THE SURGEON'S PREFERENCE TO REPLACE THE HELICAL BLADE WITH THE SCREW. ACCORDING TO THE SURGEON, THERE WERE NO OBVIOUS ERRORS IN THE ORIGINAL SURGERY OR IMPLANT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 95MM STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7947127 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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-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