TFN-ADVANCE 04.038.100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098511), received between Jun 15, 2018 and Jan 25, 2023 — classified as 1 injury, 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); 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.

• MalfunctionJan 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 A SURGEON'S PATIENT PRESENTED WITH A TFNA NAIL WITH OVER PROTRUDING LAG SCREW APPEARING TO BE COLLAPSED PAST THE GROOVE IT'S SUPPOSED TO COLLAPSE ON. THE SURGEON REINSERTED THE SAME LAG SCREW BACK INTO THE TFNA NAIL AND RE-LOCKED THE SET SCREW. AN X-RAY CONFIRMED LAG SCREW AND SET SCREW TO BE APPROPRIATELY POSITIONED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAIN INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TFNA SCREW 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242057 ↗
• InjuryJun 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTRACTION OF A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA )NAIL ON (B)(6) 2018 DUE TO SCREW CUT OUT. THE PATIENT THEN UNDERWENT A TOTAL HIP REPLACEMENT. PATIENT OUTCOME WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAYED REPORTED. CONCOMITANT DEVICES INVOLVED: TFNA SCREW 100MM STERILE (PART #04.038.100S, LOT # UNKNOWN, QUANTITY # 1), TFNA INTERMEDIATE NAIL ( PART # 04.037.144S, LOT # H491637, QUANTITY # 1), TITANIUM DISTAL LOCKING SCREW ( PART # 04.005.528S, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7607293 ↗

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-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