NA 456.304Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982226693), received between Jul 13, 2018 and Jun 25, 2020 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 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 SURGEON REMOVED ALL THREE TROCHANTERIC FIXATION NAIL (TFN) TO THE PATIENT NOT HEALING AND NEEDING TO CONVERT TO A TOTAL HIP. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE (PART NUMBER 456.315S, LOT H053179, QUANTITY 1), 5.0MM TI LOCKING SCREW 38MM- FOR IM NAILS (PART NUMBER 458.938, LOT H856858, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 11.0MM TI HELICAL BLADE 95MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10194893 ↗
• InjuryJul 13, 2018Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION ON (B)(6) 2018 TO REMOVE THE ORIGINALLY IMPLANTED TITANIUM HELICAL BLADE, SINCE IT WAS TOO LONG AND WAS PROTRUDING OUT OF THE PATIENT'S BONE, AND WAS REPLACED WITH A 20MM SHORTER HELICAL BLADE. THERE WAS ALSO DELAYED HEALING AND DISCOMFORT REPORTED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH UNKNOWN PATIENT OUTCOME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Discomfort; Failure of Implant; Impaired Healing

  MAUDE report 7685801 ↗

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.