NA 456.308SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982226785), received between Mar 8, 2018 and Mar 10, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionMar 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A HELICAL BLADE/SCREW EXTRACTOR AND A HELICAL BLADE WERE STUCK TOGETHER. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812361 ↗
• InjuryMar 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A TROCHANTERIC FIXATION NAIL (TFN) IMPLANT CUT-OUT. THE FEMORAL HEAD COLLAPSED AROUND THE FEMORAL NECK AND THE HELICAL BLADE CUT INTO THE PELVIS. IT REQUIRED IMPLANT REMOVAL ON (B)(6) 2018. THERE WAS NO FALL REPORTED BY PATIENT. CONCOMITANT DEVICE REPORT: [5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS] (PART #:458.942, LOT #: UNKNOWN, QUANTITY: 1). THIS COMPLAINT IS FOR ONE (1) DEVICE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7325798 ↗

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.