PHOENIX ANKLE NAIL SYSTEM 14-440221Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868093616), received between Mar 2, 2020 and Jun 3, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY FOR A FRACTURED ANKLE NAIL. APPROXIMATELY ONE (1) MONTH AGO, THE FRACTURED NAIL WAS REMOVED AND REPLACED WITH A COMPETITOR NAIL PRODUCT. THE INITIAL SURGERY DATE IS UNKNOWN, AND NO OTHER COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19455324 ↗
• MalfunctionJul 7, 2021Fracture; Fracture

  IT WAS REPORTED A POSTERIOR/ANTERIOR CORTICAL SCREW WAS INSERTED INTO THE ANKLE PHOENIX NAIL TO A PATIENT WITH CHARCOT DEFORMITY. DURING FOLLOW UP CHECKUPS IN CLINIC, IT WAS DISCOVERED THAT THE SCREW BROKE MONTHS AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12127802 ↗
• InjuryJul 7, 2020Fracture; Fracture

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

  Patient problems: No Code Available

  MAUDE report 10239872 ↗
• MalfunctionMar 2, 2020Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9774666 ↗

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.