TFN-ADVANCE 04.037.256SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982097361), received between Nov 2, 2018 and Apr 24, 2025 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE 12/130 DEG TI CANN TFNA 360/RIGHT-SILE BROKE UPON ATTEMPTED REMOVAL FROM THE PATIENT. APPROPRIATE INSTRUMENTATION WAS USED TO REMOVE BROKEN HARDWARE (DISTAL PORTION OF TFNA NAIL). THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898560 ↗
• InjuryJan 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON IMPLANTED A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED HELICAL BLADE, TITANIUM LOCKING SCREW WITH T25 STARDRIVE, AND A 130 DEGREES TITANIUM CANNULATED. THE PATIENT DEVELOPED A RASH SHORTLY AFTER THE PROCEDURE. AS OF (B)(6) 2019, THE RASH HAD GONE AWAY. THE SURGICAL DELAY IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 360MM/RIGHT-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Rash

  MAUDE report 8281779 ↗
• InjuryNov 6, 2018Entrapment of Device; Malposition of Device; Entrapment of Device; Malposition of Device

  THE X-RAY WAS TAKEN ON (B)(6) 2018 AND SHOWN TO THE SALES CONSULTANT ON (B)(6) 2018. THE LAG SCREW HAD COLLAPSED INTO THE NAIL. THIS IS AN INTENDED DESIGN OF THE TFNA, HOWEVER THE SURGEON HAS THE OPTION TO LACK THE LAG SCREW IN A RIGID CONSTRUCT WHICH HE DID. HIS INTENTION WAS TO HOLD THE REDUCTION IN A STATIC POSITION; INSTEAD THE LAG SCREW COLLAPSED INTO THE NAIL.

  Patient problems: No Code Available

  MAUDE report 8043304 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT OUTCOME WAS SATISFACTORY.

  Patient problems: No Code Available

  MAUDE report 8032471 ↗

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-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-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-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