NA 456.421SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982227874), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryJan 11, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OF A TROCHANTERIC FIXATION NAIL (TFN) WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN NAIL AND NON-UNION. THE ORIGINAL PROCEDURE WAS PERFORMED IN (B)(6) 2017. THE REMOVED HARDWARE INCLUDED: ONE (1) 11MM X 400MM TFN NAIL (BROKEN BELOW THE HOLE FOR HELICAL BLADE), ONE (1) INTACT HELICAL BLADE AND ONE (1) INTACT LOCKING SCREW. IT IS NOTED THAT BEFORE THE ORIGINAL PROCEDURE, THE PATIENT WALKED WITH A LIMP. REGARDING THE NON-UNION, IT WAS NOTED THAT THE MEDIAL SIDE OF THE ORIGINAL FRACTURE SHOWED HEALING, THE LATERAL SIDE OF THE ORIGINAL FRACTURE DID NOT. THE HARDWARE WAS REMOVED WITHOUT INCIDENT. THE PATIENT WAS REVISED TO A NEW TFN CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 11.0MM HELICAL BLADE 105MM (456.306S, LOT H045635, QUANTITY 1), LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7184233 ↗

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.