NA 456.301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982226631), received between Jan 9, 2018 and Jan 13, 2020 — classified as 2 injuries.

7 other recalls cover devices cleared under the same FDA submission (K011857); 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.

• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, ONE (1) TROCHANTERIC FEMORAL NAIL, ONE (1) HELICAL BLADE, ONE (1) UNKNOWN LOCKING SCREW, AND ONE (1) UNKNOWN CABLE WIRE WERE REMOVED DUE TO NONUNION. THE PATIENT HAD A TUMOR IN THE PROXIMAL FEMUR. THE FEMUR WAS RESECTED AND A TOTAL HIP WAS DONE. ALL HARDWARE CAME OUT SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 80MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9582492 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TROCHANTERIC FIXATION NAIL, HELICAL BLADE, AND UNKNOWN SCREWS ON A UNKNOWN DATE. THE PATIENT SUBSEQUENTLY EXPERIENCED A NON-UNION AND THESE PARTS WERE REMOVED. THE REMOVED DEVICES WERE INTACT. THE PATIENT WAS REVISED TO A PLATE. THERE WAS NO SURGICAL DELAY. NO INFORMATION REGARDING THE PATIENT STATUS AS WELL THE PROCEDURE STATUS WAS PROVIDED. THIS COMPLAINT INVOLVES THREE (3) PARTS. THIS REPORT IS FOR A HELICAL BLADE. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7175064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011857. One submission often covers many models, so check the product and lot details in each record.

• Z-0604-2018 · Jul 21, 2017 · Terminated
  11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
• Z-0375-2016 · Nov 2, 2015 · Terminated
  Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Naili
• Z-0219-2015 · Oct 29, 2014 · Terminated
  10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
• Z-0387-2014 · Jul 31, 2013 · Terminated
  Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrocha
• Z-0474-2014 · Jul 30, 2013 · Terminated
  Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal
• Z-0452-2014 · Jul 30, 2013 · Terminated
  Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.