TFN-ADVANCE 04.037.115SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982096333), received between Oct 2, 2020 and Apr 24, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A TFNA IN (B)(6) 2022. THE NAIL WAS REMOVED ON (B)(6) 2023 DUE TO A PERIPROSTHETIC FRACTURE OCCURRING DISTAL TO THE SHORT TFNA. THE FRACTURE WAS NOTICED ALONG THE SHAFT OF THE NAIL. THE SURGEON SUSPECTS THAT THE FRACTURE WAS THERE BEFORE THE NAIL WAS PLACED. DURING THE PROCEDURE, THE RUBBER TIPS ON THE REAMING ROD WERE HARD TO REMOVE, HOWEVER THEY WERE REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 11MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 16797906 ↗
• InjuryApr 4, 2023Break; Break

  DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE PATIENT EXPERIENCED BREAKAGE OF THE TFNA NAIL JUST UNDER THE COLUMN SCREW. THE EVENT OCCURRED 3 MONTHS AFTER THE INITIAL IMPLANTATION. SURGERY WAS PERFORMED TO REMOVE THE BROKEN TFNA AND TO IMPLANT A NEW, THICKER AND LONGER TFNA. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 11MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16674981 ↗
• InjuryJun 27, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT PRESENTED WITH A TFNA NAIL THAT CUTOUT PROXIMAL THROUGH FEMORAL HEAD. ALL IMPLANTS WERE IN TACT, NOT BROKEN. THE SURGEON REMOVED TFNA IMPLANTS AND CONVERTED TO A ZIMMER BIOMET TOTAL HIP. THERE WAS PATIENT CONSEQUENCES. THIS COMPLAIN INVOLVES ONE(1) DEVICE 11/125 DEG TI CANN TFNA 235/LEFT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 14830871 ↗
• InjuryMar 26, 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 WAS UNDERWENT A REVISION OF FEMUR NAIL DUE TO ANTERIOR THIGH PAIN. THERE WAS NO SURGICAL DELAY WAS REPORTED. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 13922890 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY (IM) NAILING OF INTERTROCHANTERIC FRACTURE ON (B)(6) 2020, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED SCREW GOT STUCK IN THE TFNA NAIL AND COULD NOT BE ADVANCED OR PULLED BACK. THE NAIL WAS ABLE TO BE REMOVED AND EXCHANGED WITH ANOTHER NAIL. A SECOND TFNA SET WAS USED TO PROCEED WITH THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA SCREW INSERTER (PART # 03.037.025 LOT # L503499, QUANTITY 1), CONNECTING SCREW FOR TFNA HELICAL BLADE AND SCREW (PART # 03.037.026 LOT # L987541, QUANTITY 1), EXTRACTION INSTRUMENT FOR TFNA HELICAL BLADE AND SCREW (PART # 03.037.030, LOT # 534061, QUANTITY 1); TFNA FENESTRATED SCREW 85MM (PART # 04.038.185, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TFNA 235MM/LEFT, STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621596 ↗

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