TFN-ADVANCE 04.038.280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098955), received between Dec 5, 2017 and Jul 30, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED IN (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY BY USING A COMPETITORS FEMORAL IMPLANT SYSTEM IN ORDER TO PREVENT BONE FRACTURES DUE TO THE BREAST CANCER BEING SPREAD TO THE FEMUR. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO REPLACE THE FEMORAL IMPLANTS DUE TO DEVICE BREAKAGE WITH SYNTHES TROCHANTERIC FIXATION NAIL ANTIROTATION (TFNA) LONG IMPLANTS. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF THE TFNA LONG IMPLANTS. THE PATIENT WAS REVISED TO ANOTHER SET OF IMPLANTS. THERE WAS A ONE (1) HOUR SURGICAL DELAY DUE TO EXTENDED TIME IN REMOVING THE BROKEN DEVICE. IT WAS FURTHER REPORTED THE PATIENT ALSO HAD A NON-UNION WHICH MAY HAVE CONTRIBUTED TO THE DEVICE BREAKAGE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10343668 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A INTERTROCHANTERIC HIP FRACTURE. THE FRACTURE WAS CONFIRMED WITH X-RAYS. THE SURGEON TOOK THE PATIENT TO THE OPERATING ROOM ON (B)(6) 2017 AND PATIENT WAS IMPLANTED WITH A LONG TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL WITH HELICAL BLADE AND DISTAL LOCKING SCREWS. ON (B)(6) 2017, AN X-RAY DURING NORMAL FOLLOW UP SHOWED THE FEMORAL HEAD STARTING TO SLIGHTLY COLLAPSE. THE SURGEON ELECTED TO WAIT AND WATCH THE FRACTURE. X-RAY ON (B)(6) 2017 SHOWED FURTHER COLLAPSE OF THE HEAD INTO VARUS. ON (B)(6) 2017, SURGEON TOOK THE PATIENT BACK TO THE OPERATING ROOM TO REMOVE THE TFNA NAIL, THE TFNA HELICAL BLADE, AND TWO LOCKING SCREWS AND TOOK CULTURES. NONE OF THE IMPLANTS WERE BROKEN AND THE REMOVAL WAS A SUCCESS. A HEMI-ARTHROPLASTY WAS PERFORMED IN PLACE OF THE HARDWARE REMOVAL. CONCOMITANT PARTS: 5.0MM TI LOCKING SCREW WITH T25 STRARDRIVE 40MM F/IM NAIL (PART NUMBER: 04.005.530S, LOT NUMBER: H359595, QUANTITY 1), 5.0MM TI LOCKING SCREW WITH T25 STARDRIVE 38MM F/IM NAIL (PART NUMBER: 04.005.528S, LOT NUMBER: H329932, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 80MM STERILE. THIS IS REPORT 2

  Patient problems: No Code Available

  MAUDE report 7084289 ↗

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-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-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-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