NA 702478Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540112262), received between Mar 31, 2023 and Jun 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJun 25, 2025Residue After Decontamination; Naturally Worn; Residue After Decontamination; Naturally Worn

  DURING REPROCESSING AT THE STERILIZATION DEPARTMENT THE STAFF OBSERVED CHANGES IN THE SURFACE OF THE AFFECTED ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327263 ↗
• MalfunctionMar 31, 2023Break; Material Fragmentation; Break; Material Fragmentation

  AS REPORTED, "ORIF WAS PERFORMED FOR ANKLE FRACTURE USING VARIAX 2 FIBULA PLATE AND ASNIS 4.0MM. X-RAY TAKEN AFTER THE PLATED WAS PLACED TO THE TARGET SITE REVEALED THAT THERE WAS WHAT APPEARED TO BE A PIECE OF METAL AT THE SITE. THE METAL PIECE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660552 ↗