PHOENIX ANKLE NAIL SYSTEM 14-440115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868093531), received between Jul 18, 2023 and Dec 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K081243, K091976); 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.

• MalfunctionDec 18, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANTATION, THE DRILL MISSED THE NAIL AND CAUSED A DRILL HOLE THE SIZE OF THE DRILL BIT. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteopenia/ Osteoporosis

  MAUDE report 18344829 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 17342618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081243, K091976. One submission often covers many models, so check the product and lot details in each record.

• Z-1236-2018 · Mar 12, 2018 · Terminated
  Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-4
• Z-1819-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.