NA 456.305SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982226723), received between May 21, 2018 and Apr 15, 2021 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN INTRAMEDULLARY FEMORAL NAIL PROCEDURE, THE TI HELICAL BLADE AND THE TI TROCHANTERIC FIXATION NAIL WERE STUCK TOGETHER. UPON INSERTION OF THE TI HELICAL BLADE THROUGH THE TI TROCHANTERIC FIXATION NAIL, IT COLLIDED WITH THE INTERNAL LOCKING MECHANISM. BOTH IMPLANTS WERE REMOVED AND REPLACED SUCCESSFULLY USING BACK UP DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673462 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FIXATION NAIL (TFN) DEVICES DUE TO NON-UNION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10680717 ↗
• InjuryMay 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL (TFN) FOR A LEFT HIP, STATUS POST FALL ON (B)(6) 2018. THE PATIENT UNDERWENT REMOVAL OF THE TROCHANTERIC FIXATION NAIL DUE TO MEDIAL MIGRATION OF HELICAL BLADE SECONDARY TO FALL AND WAS CONVERTED TO LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2018. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE (PART #: 456.328S, LOT #: H446334, QUANTITY: 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART #: 04.005.528, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 11.0MM TI HELICAL BLADE 100MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529184 ↗

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.