TFN-ADVANCE 04.037.234SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982097200), received between Dec 19, 2018 and Jul 29, 2020 — 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, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SET SCREW NOT ENGAGING WITH THE LAG SCREW INSIDE THE NAIL DURING A NAILING PROCEDURE ON (B)(6) 2020. THE NAIL WAS REMOVED AND A SECONDARY NAIL IMPLANTED SUCCESSFULLY. THERE WAS AN UNKNOWN TIME OF SURGICAL DELAY DUE TO THE NAIL EXCHANGE INTRAOPERATIVELY. CONCOMITANT DEVICES: UNKNOWN LAG SCREW (PART/LOT# UNKNOWN, QTY1). UNKNOWN LOCKING SCREWS (PART/LOT # UNKNOWN, QTY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338979 ↗
• InjuryDec 19, 2018Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION HIP SURGERY ON AN UNKNOWN DATE. A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL CUT OUT THROUGH THE TOP. HARDWARE REMOVAL OF ALL IMPLANTS, INCLUDING A HELICAL BLADE AND TWO (2) DISTAL LOCKING SCREWS LOCATED AT THE MOST DISTAL HOLE OF THE NAIL AND THE DYNAMIC HOLE. THE NAIL WAS IMPLANTED IN (B)(6) 2018. THE SURGEON REPLACED THE DEVICE WITH A BIOMET CEMENTED HEMI HIP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). HELICAL BLADE (PART# 04.038.300, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8180457 ↗

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