NA 456.307Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982226754), received between Oct 11, 2018 and May 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON HAD AN ISSUE GETTING THE HELICAL BLADE THROUGH THE TROCHANTERIC FIXATION NAIL (TFN) DURING A PROCEDURE ON (B)(6) 2020. THE HELICAL BLADE MADE CONTACT WITH THE LEFT HAND SIDE/PROXIMAL PART OF THE HOLE GLIDING HOLE. THE TFN AND HELICAL BLADE IMPACTS WERE REMOVED AND A NEW NAIL AND BLADE WERE USED WITH NO CONFLICT. THERE IS A POSSIBILITY THE CONNECTING SCREW THAT CONNECTS TO THE TFN WAS LOOSE HOWEVER, THERE WERE NO ISSUES WITH INSTRUMENTS WHEN TESTING THE IMPLANTS POST SURGERY. THERE WAS A 5 MINUTE SURGICAL DELAY BUT NO PATIENT COMPLICATIONS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10075625 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL OF A TROCHANTERIC FIXATION (TFN) INTRAMEDULLARY NAIL AND A HELICAL BLADE DUE TO MALUNION. THE SURGEON DETERMINED THAT THE MALUNION WAS NOT A RESULT OF HARDWARE FAILURE. THE ORIGINAL PROCEDURE WAS DONE ON (B)(6) 2018. DURING REVISION SURGERY, THE SURGEON RE-REDUCED THE FRACTURE AND IMPLANTED A NEW INTRAMEDULLARY NAIL. THERE ARE NO REPORTS OF SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 110MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7956260 ↗

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.