NA 456.357SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982227294), received between Jan 22, 2018 and Jan 22, 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 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.

• InjuryJan 22, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF A BROKEN 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER ON (B)(6) 2017. INITIALLY THE PATIENT FELL AND FRACTURED HER HIP, FOR WHICH A 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER WAS IMPLANTED IN (B)(6) 2017. THE PATIENT SUFFERED FROM SEIZURE AND FAINTING DISORDERS AND ON ACCOUNT OF THIS SHE SUSTAINED ANOTHER FALL BREAKING HER NAIL THROUGH THE HELICAL BLADE HOLE IN THE NAIL. THE BROKEN NAIL WAS REMOVED DURING THE REVISION SURGERY WITHOUT INCIDENT ALONG WITH AN INTACT HELICAL BLADE AND TWO INTACT UNKNOWN LOCKING SCREWS. THE FEMUR WAS REAMED TO A LARGER SIZE AND AN 11X360, 125 DEGREES, LEFT TFN WAS IMPLANTED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT MEDICAL PRODUCTS: UNK - NAIL HEAD ELEM: TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QTY # 1), UNK - SCREWS: LOCKING: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QTY # 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hip Fracture

  MAUDE report 7210344 ↗

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.