TFN-ADVANCE 04.037.464SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982097682), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT A PATIENT EXPERIENCED A POST-OP DISPLACEMENT OF A FRACTURE. THE PATIENT RECEIVED THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANT ON (B)(6) 2020. A SURGEON, THAT DID NOT PERFORM THE INITIAL SURGERY, NOTED THAT THE HELICAL BLADE WAS INSERTED OUTSIDE OF THE HOLE IN THE NAIL. THE IMPROPER PLACEMENT OF THE HARDWARE CAUSED THE CONSTRUCT TO COLLAPSE. WHEN THE PATIENT TRIED TO WALK ON IT, THE FRACTURE BECAME DISPLACED AND THE PATIENT REQUIRED REVISION SURGERY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE HARDWARE WAS SUCCESSFULLY REMOVED, AND NEW HARDWARE WAS IMPLANTED. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), TFNA FENESTRATED HELICAL BLADE 100MM (PART NUMBER 04.038.400, LOT 4OP2323, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 14MM/130 DEG TI CANN TFNA 440MM/RIGHT-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10487938 ↗

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-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-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-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