TFN-ADVANCE 04.038.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982099020), received between Mar 20, 2017 and May 15, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT CAME IN WITH A DISTAL FEMUR FRACTURE ON THE SAME SIDE BELOW THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE HELICAL BLADE WAS REMOVED BECAUSE IT WAS IN THE WAY OF THE PLATE. THERE WAS NO PROBLEM WITH THE IMPLANT AND NO IMPLANT FAILURE. THERE WAS PROMINENCE FROM THE NORMAL COLLAPSE THAT HAPPENED TO BE IN THE WAY. AN INTERLOCKING SCREW WAS REMOVED AS WELL. THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2016. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS WAS NORMAL. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 100MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8612172 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2018. THE PATIENT WAS INITIALLY TREATED FOR AN INTERTROCHANTERIC FRACTURE ON (B)(6) 2017 WHEN THE PATIENT WAS IMPLANTED WITH ONE (1) 11 MM/130-DEGREE TFNA SHORT NAIL, TFNA 100 MM HELICAL BLADE AND A 5.00 MM LOCKING SCREW. THE REMOVAL SURGERY WAS PERFORMED DUE TO THE PATIENT¿S POOR BONE QUALITY. SURGEON REMOVED THE SHORT TFNA NAIL AND REVISED IT TO A TOTAL HIP. THE SURGEON ALSO REMOVED THE LOCKING SCREW AND THE 100MM BLADE. THE REMOVAL SURGERY WENT WITHOUT ANY COMPLICATIONS. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT IS FOR A TFNA HELICAL BLADE 100MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 7496352 ↗
• InjuryApr 12, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, HELICAL BLADE, AND 5.0 MM LOCKING SCREW ON (B)(6) 2018. ON UNKNOWN DATE AN ANTERIOR CUTOUT OF THE HELICAL BLADE AND FEMORAL HEAD COLLAPSE WERE DETECTED. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO A HIP ARTHROPLASTY. CONCOMITANT DEVICES REPORTED: 12 MM 130 DEGREE TITANIUM CANNULATED TFNA NAIL 170 MM (04.037.242S, LOT H464168, QUANTITY 1), 5.0 MM LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 100 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7425848 ↗
• InjuryDec 7, 2017Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  IT WAS REPORTED THAT A PATIENT HAD A FALL ON (B)(6) 2015 AND WENT TO THE EMERGENCY ROOM WITH RIGHT HIP PAIN. X-RAYS REVEALED ACUTE NONDISPLACED INTERTROCHANTERIC FRACTURE OF THE RIGHT PROXIMAL FEMUR. PATIENT WAS IMPLANTED WITH A SYNTHES TROCHANTERIC FEMORAL NAIL, HELICAL BLADE AND WITH A DISTAL INTERLOCKING SCREW ON (B)(6) 2015. THE PATIENT COMPLAINED OF RIGHT GROIN PAIN FOR SEVERAL WEEKS POSTOPERATIVELY. ON (B)(6) 2017 A X-RAY SHOWED A HELICAL BLADE HAS MIGRATED INTO THE ACETABULUM WITH SURROUNDING LUCENCY. ON (B)(6) 2017, THE PATIENT WENT FOR REVISION SURGERY DUE TO A MIGRATION. ALL HARDWARE WAS REMOVED INTACT. THERE WERE NO COMPLICATIONS NOTED AS THE TIME OF THE SURGERY. THE SURGERY WAS SUCCESSFUL WITH NO DELAY OR MEDICAL INTERVENTION NOTED. THE FRACTURE HAD HEALED AND DO NOT NEED TO BE REVISED TO ANY HARDWARE. THE DEVICES ARE NOT BEING RETURNED. THE PATIENT WAS DOING WELL. CONCOMITANT DEVICES REPORTED: 11MM/130 DEGREE TI CANN TFNA 170MM - STERILE (PART #: 04.037.142S, LOT #: 9938768, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART # 04.005.528, LOT #: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 100MM. THIS IS REPORT 1 OF 1 FOR

  Patient problems: Failure of Implant; Pain

  MAUDE report 7096915 ↗
• InjuryNov 22, 2017Unintended Movement; Unintended Movement

  FURTHER IT WAS REPORTED THAT A PATIENT UNDERWENT A SERIES OF SURGERIES FOLLOWING THE MOVEMENT OF A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM'S COMPONENTS CAUSED DUE TO FAILURE OF ONE (1) UNKNOWN LOCKING BOLT OR SCREW, WHICH LED TO AN UNKNOWN COMPONENT OF THIS SYSTEM TO PROTRUDE EXCESSIVELY INTO PATIENT'S FEMUR. THERE IS ALSO AN ALLEGATION OF AN UNKNOWN VICE OR DEFECT ON THE TFN SYSTEM THAT CANNOT BE SEEN BY ORDINARY TESTS AND THAT HAD OCCURRED DURING MANUFACTURING. THIS TFN SYSTEM WAS INITIALLY IMPLANTED ON (B)(6) 2017 INTO THE PATIENT'S FEMUR. DUE TO THE PROTRUSION OF THE DEVICE, THE PATIENT ALLEGEDLY WAS UNABLE TO BE FULLY FUNCTIONAL FOR MANY MONTHS. THE PATIENT IS REPORTEDLY PARTIALLY DISABLED, I.E. THEY CANNOT ENGAGE IN ALL OF THE ACTIVITIES OF THEIR WORK. SUBSEQUENT SURGERIES WERE UNABLE TO FULLY REPAIR THE DAMAGE TO PATIENT'S BODY CAUSED BY THE TFN SYSTEM. THERE IS A MENTION OF SEVERAL ADDITIONAL SURGERIES THAT THE PATIENT HAD TO UNDERGO SUBSEQUENT TO THIS TFN SYSTEM¿S UNKNOWN DEVICE MIGRATION. THE MOVEMENT OF TFN COMPONENT LEADING TO REVISION SURGERY HAS BEEN CAPTURED UNDER: (B)(4).

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7052789 ↗
• InjuryAug 21, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC PROXIMAL FEMORAL NAIL-ADVANCED (TFNA) NAIL, HELICAL BLADE, AND LOCKING SCREW ON (B)(6) 2017 DUE TO DEVICE FAILURE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2017 AND FAILED ON AN UNKNOWN DATE POSTOPERATIVELY. THE HELICAL BLADE WAS NO LONGER IN THE FEMORAL NECK AND WAS IN THE ACETABULUM. THE LOCKING MECHANISM OF THE NAIL FAILED AND THE SURGEON COULD NOT REMOVE THE HELICAL BLADE FROM THE NAIL. THE SURGEON REMOVED FEMORAL HEAD AND NECK AND PERFORMED A GIRDLESTONE PROCEDURE . THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) HELICAL BLADE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6808264 ↗
• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT THE PATIENT UNDERWENT A REMOVAL OF A TFN-ADVANCED¿ PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO A NON-UNION AND INFECTION ON (B)(6) 2017. CULTURES WERE TAKEN PRIOR TO THE PROCEDURE AND IT WAS DETERMINED THE HIP FRACTURE WAS AN INFECTED NON-UNION. ONE (1) 12MM/130 DEGREE TITANIUM CANNULATED TFNA 380MM/LEFT-STERILE AND ONE (1) TFNA HELICAL BLADE 100MM WERE REMOVED INTACT. THE PATIENT RECEIVED ANTIBIOTIC CEMENT OVER A RUSH ROD PLACED IN THE FEMUR. NO SURGICAL DELAYS. NO REPORTED PATIENT HARM. DATE OF IMPLANT IS UNKNOWN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 6419129 ↗

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-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