PHOENIX ANKLE NAIL SYSTEM 14-440315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868093654), received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN. DURING THE SURGERY, IT WAS FOUND THE NAIL HAD FRACTURED. THE DISTAL PART OF THE NAIL WAS LEFT IN THE PATIENT, AS IT COULDN'T BE REMOVED BECAUSE IT WAS INCORPORATED IN THE BONE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 10145851 ↗

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.