TFN-ADVANCE 04.038.305SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982099051), received between Mar 15, 2018 and Apr 29, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT ON UNKNOWN DATE, THE PATIENT PRESENTED WITH 235MM TFNA AND NON UNION AFTER 5 MONTHS OF SURGERY FOR AN INTERTROCH FRACTURE. THERE WAS ALSO A LATERAL FEMORAL WALL FRACTURE BELOW THE BLADE HOLE. THE NAIL BROKE AT THE PROXIMAL HOLE. THE NAIL AND BLADE WERE REMOVED AND REVISED TO A LONG TFNA AND LAG SCREW. THE STATUS OF THE PATIENT POST HARDWARE REMOVAL WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 105MM STERILE DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14250449 ↗
• InjuryMar 9, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 FOLLOW UP X-RAYS SHOWED THAT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HELICAL BLADE HAD CUT THROUGH THE ACETABULUM AND ENTERED THE PELVIS. THE BLADE APPEARED FREE IN ROTATION ON THE POST OP X-RAYS; AN ANGIO CT WAS PREFORMED AND NO VESSEL DAMAGE WAS NOTED. THE TFNA WAS REMOVED AND THE HELICAL BLADE WAS EXTRACTED ON (B)(6) 2021. THE LOCKING MECHANISM WAS NOT ENGAGED AND DURING THE REMOVAL OF THE NAIL, THE HELICAL BLADE WAS FREE IN ROTATION. THE REVISION OPERATION WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 105MM STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 11447253 ↗
• InjuryFeb 4, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HELICAL BLADE HAS IMPACTED TO THE ARTICULAR SURFACE. IT WAS MENTIONED THAT THE FRACTURE SEEMS TO BE HEALED ALREADY BEFORE THE REPORTED ISSUE OCCURRED. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS A NEED FOR ANOTHER SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 105 MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9667915 ↗
• MalfunctionJun 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(3) 2019 DURING A TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA), THE TFNA HELICAL BLADE GOT STUCK IN THE TFNA HELICAL-BLADE IMPACTOR AND WAS NOT POSSIBLE TO DISCONNECT FROM THE TFNA HELICAL-BLADE IMPACTOR AND GUIDE SLEEVE. COMPRESSION/DISTRACTION NUT CANNOT BE DISENGAGED FROM YELLOW GUIDE SLEEVE. HELICAL BLADE CANNOT BE DISENGAGED FROM HELICAL BLADE INSERTER/CONNECTING SCREW AND PIN WRENCH. THEY ARE ALL CONNECTED TOGETHER AND CANNOT BE DISENGAGED. WHEN THE EVENT OCCURRED, THE SURGEON REMOVED THE IMPLANT AND USED ANOTHER SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TFNA BLADE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693172 ↗
• InjuryMar 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL EXCHANGE WAS PERFORMED ON (B)(6) 2018 DUE TO A SPIRAL BLADE BACKING OUT. THE INITIAL SURGERY WAS FOR A TFNA ROUGHLY SIX WEEKS AGO. THE NAIL AND BLADE WERE REMOVED SUCCESSFULLY AND INTACT. THE REVISION SURGERY WAS SUCCESSFUL. THERE WERE NO SURGICAL DELAYS AND NO X-RAYS ARE AVAILABLE. PATIENT OUTCOME WAS SATISFACTORY. CONCOMITANT PART: 11MM/130 DEGREE TI CANN TFNA (PART: 04.037.144S, LOT: H441055, QUANTITY ONE) . (B)(4).

  Patient problems: No Code Available

  MAUDE report 7341715 ↗

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-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-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-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