NA 456.311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982226839), received between Nov 6, 2017 and Feb 3, 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.

• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF BILATERAL TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAILS IN BOTH RIGHT AND LEFT LEGS DUE TO NON-UNION AND INFECTION. FOR THE RIGHT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) HELICAL BLADE, AND TWO (2) UNKNOWN 5.0MM SCREWS WERE REMOVED. FOR THE LEFT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) END CAP, ONE (1) HELICAL BLADE, AND ONE (1) UNKNOWN 5.0MM SCREW WERE REMOVED. THE RIGHT LIMB INCURRED A SECONDARY FRACTURE OF THE PROXIMAL FEMUR UPON THE NAIL REMOVAL. THIS FRACTURE WILL BE ADDRESSED AT A LATER DATE. THERE WAS NO SURGICAL DELAY. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TI END CAP FOR TROCHANTERIC FIXATION NAILS 0MM EXT. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9662070 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 TO REMOVE A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM FOR A CONVERSION TO A TOTAL HIP REPLACEMENT. THE PATIENT WAS INITIALLY IMPLANTED ON AN UNKNOWN DATE. POST-OPERATIVELY THE PATIENT HAD FALLEN AND BROKE HER FEMUR AGAIN. CABLES WERE IMPLANTED TO HOLD THE BONE TOGETHER BEFORE REMOVAL OF NAIL, THEN CONTINUED ON TO COMPLETE THE HIP REPLACEMENT. DURING THE REVISION THE TFN NAIL, HELICAL BLADE, LOCKING SCREW AND END CAP WERE EASILY REMOVED, WHOLE AND INTACT. THERE WAS NO SURGICAL DELAY. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO DEVICE MALFUNCTIONS OCCURRED DURING THE REVISION. THE PATIENT RECEIVED A TOTAL HIP REPLACEMENT. PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) TI END CAP FOR TROCHANTERIC FIXATION NAILS 0MM EXT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7002816 ↗

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.