NA 456.414SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982227805), received between Feb 8, 2018 and Feb 21, 2018 — 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 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A REVISION SURGERY ON AN UNKNOWN DATE FOR REMOVAL ONE 5.0 MM DISTAL LOCKING SCREW IN ORDER TO DYNAMIZE THE CONSTRUCT TO INDUCE CALLUS FORMATION AND SUBSEQUENT HEALING AS THERE WAS A DELAYED UNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TFN NAIL, A HELICAL BLADE AND ONE 5.0 MM DISTAL LOCKING SCREW FOR TREATMENT OF PROXIMAL FEMUR FRACTURE ON (B)(6) 2015. THE SCREW WAS REMOVED INTACT AND UNEVENTFULLY. NO OTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7286853 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WILL HAVE TO UNDERGO A REVISION SURGERY ON (B)(6) 2018 FOR REMOVAL OF A TFN NAIL, A HELICAL BLADE AND ONE 5.0MM DISTAL LOCKING SCREW DUE TO NON-UNION. THE HARDWARE WAS IMPLANTED FOR TREATMENT OF PROXIMAL FEMUR FRACTURE ON (B)(6) 2015. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018. IT WAS AN EXCHANGE NAILING FOR NONUNION OF AN ATYPICAL SUBTROCHANTERIC FEMUR FRACTURE. ONE 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER AND 11.0MM TI HELICAL BLADE 85MM WERE REMOVED INTACT WITHOUT ANY COMPLICATION. AFTER THE REMOVAL OF THE HARDWARE, ANOTHER 14MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER, ONE 11.0MM TI HELICAL BLADE 85MM AND ONE 5.0MM TI LOCKING SCREW 48MM-FOR IM NAILS WERE IMPLANTED IN THE PATIENT. ADDITIONALLY, THE SURGEON USED BONE MARROW ASPIRATE CONCENTRATE AND CANCELLOUS CHIP GRAFT. THE PATIENT WAS STABLE AFTER THE SURGERY. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS PER THE SALES CONSULTANT THE 5.0MM DISTAL LOCKING SCREW IMPLANTED ON (B)(6) 2015 WAS REMOVED DURING A INTERVENING SURGERY DONE ON AN UNKNOWN DATE BETWEEN (B)(6) 2015 AND (B)(6) 2018 IN AN ATTEMPT TO DYNAMIZE THE CONSTRUCT TO INDUCE C

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7253268 ↗

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.