TFN-ADVANCE 04.037.944SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098047), received between Dec 1, 2018 and Apr 13, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

8 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.

Recalls naming this device

1. Jan 24, 2024Class IIOpen, Classified

   Products not sterilized, sterility cannot be confirmed

   Z-1239-2024 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryApr 13, 2021Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A SURGEON HEARD OF A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) TFNA NAIL. THE NAIL HAD BROKEN AT THE JUNCTION OF THE BLADE/NAIL. THIS REPORT IS FOR A 9MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655774 ↗
• InjuryDec 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING HIP SURGERY, THE SALES CONSULTANT (SC) PASSED OFF THE WRONG DEGREE OF THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) TO THE FIELD. THE SURGEON ASKED FOR A 125 BUT A 130 NAIL WAS PASSED BY HIM. THE BLADE WOULD NOT ENTER INTO THE HEAD OF THE PATIENT AND BEGAN TO RUN THROUGH POSSIBLE SCENARIOS. SC CHECKED THE BOX IN THE TRASH AND IT WAS A 130 NAIL. THE NAIL WAS REMOVED, AND THE CORRECT NAIL WAS PASSED TO THE FIELD. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES AND THEN PROCEEDED. THIS REPORT IS FOR ONE (1) 9MM/130 DEG TI CANN TFNA 235MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8121851 ↗

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-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-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