NA 456.308Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982226778), received between Apr 5, 2017 and Apr 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE FOR INTERTROCHANTERIC HIP FRACTURE ON (B)(6) 2017. UPON INSERTION OF HELICAL BLADE THROUGH THE NAIL, IT WAS NOTICED THAT THE PLUNGER BUILT INTO THE NAIL WAS ADVANCED, PREVENTING THE HELICAL BLADE FROM PASSING THROUGH THE NAIL. THE SURGEON PULLED THE PLUNGER BACKED UP AND CONTINUED TO INSERT HELICAL BLADE BUT IT WOULD NOT ADVANCE. HE REPOSITIONED GUIDE WIRE AND ATTEMPTED ONE MORE TIME WITH SAME RESULTS, THE HELICAL BLADE WOULD NOT ADVANCE. IT WAS DETERMINED BEST TO REMOVE THE NAIL AND HELICAL BLADE THAT WAS NOT ADVANCING AND REPLACED IT WITH ANOTHER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A TIME DELAY OF 15 MINUTES BECAUSE OF THE ATTEMPTS, REMOVAL, REASSEMBLY AND REINSERTIONS. THERE WAS NO HARM TO PATIENT AND THE PATIENT OUTCOME IS NOT AVAILABLE. THIS REPORT IS FOR ONE (1) HELICAL BLADE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6460810 ↗

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.