TFN-ADVANCE 04.037.272SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982097507), received between Aug 20, 2021 and Aug 20, 2021 — classified as 1 malfunction.

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.

• MalfunctionAug 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) PROCEDURE INTRAMEDULLARY (IM) NAILING OF FEMUR, THE SET SCREW WAS NOT PUT DOWN, AND INSTEAD REVERSED UNTIL IT BOUND ITSELF AGAINST THE CONNECTING SCREW OF THE TFNA INSERTION HANDLE. CONSEQUENTLY, THE SURGEON PLANNED TO LEAVE IT AS IS, BUT WHEN ATTEMPTING TO REMOVE THE CONNECTING SCREW, IT WOULD NOT BUDGE. AS A RESULT, THE TFNA SCREW WAS REMOVED (NO 5.0MM LOCKING SCREW WAS USED) AND TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL (STILL ATTACHED TO THE INSERTION HANDLE) WAS REMOVED. THEN A NEW NAIL WAS OPENED AND ATTACHED TO A TFNA HYBRID HANDLE. SURGEON REINSERTED THE NAIL AND FINISHED THE PROCEDURE WITH NO FURTHER PROBLEMS. NOW THE OLD NAIL IS STUCK TO THE INSERTIONS HANDLE FOR TFNA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIRTY (30) MINUTES SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 12MM/135 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350510 ↗

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-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