VariAx 40-35616SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540539427), received between Sep 14, 2015 and Sep 14, 2015 — classified as 1 malfunction.

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

• MalfunctionSep 14, 2015Mechanics Altered

  IT WAS REPORTED THAT ONE OF THE DISTAL HOLES IN THE FIBULA PLATE COULD NOT BE LOCKED WITH THE SCREW. SPARE SCREW WAS USED, BUT COULD NOT BE LOCKED WITH THE SAME HOLE. THE DISTAL HOLE WAS NOT USED AND ANOTHER HOLE WAS USED INSTEAD. THE SCREW WAS IMPLANTED THOUGH ENOUGH LOCKING WAS NOT PERFORMED. THE ANGLE OF THE SCREW WAS NOT OVER 15 DEGREES. THE DEPTH OF THE SCREW INSERTION WAS PROPER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5076511 ↗