NA 456.317SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982226921), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 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 A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) PROCEDURE, AN 11MM/125 DEGREE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (170MM) WAS INADVERTENTLY SELECTED FOR IMPLANTATION. THE SURGEON HAD DIFFICULTY WHEN ATTEMPTING TO IMPLANT THE NAIL. THE CORRECT, LARGER, NAIL (11 MM/130 DEGREE TITANIUM CANNULATED TFN-A) WAS THEN SELECTED AND SWITCHED ONTO THE AIMING ARM FOR SUCCESSFUL IMPLANTATION. THERE WAS A 20-MINUTE SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7874324 ↗

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-0452-2014 · Jul 30, 2013 · Terminated
  Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
• 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-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.