VariAx 40-35614SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540539410), received between Sep 14, 2015 and Jun 4, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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 16, 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.

• MalfunctionJun 4, 2018Mechanics Altered

  DURING VARIAX FIBULA SURGERY, THE LOCKING SCREW DID NOT LOCK IN THE MOST DISTAL HOLE. THE SCREW WAS ONCE REMOVED, REMOVAL AND CLEANING OF SOFT TISSUE WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON EXCHANGED THE SCREW WITH ANOTHER SAME SIZE SCREW, BUT THE SCREW COULD NOT BE LOCKED. THEREFORE, RE-DRILLING WAS PERFORMED USING DRILL SLEEVE BUT THE ISSUE WAS NOT RESOLVED. ULTIMATELY, THE SURGERY WAS FINISHED WITH THE SCREW UNLOCKED AND LAG SCREW FIXATION WAS ADDED USING 3.5MM NON-LOCKING SCREW IN ORDER TO INCREASE FRACTURE STABILITY.

  Patient problems: No Information

  MAUDE report 7567112 ↗
• MalfunctionJun 4, 2018Mechanics Altered

  DURING VARIAX FIBULA SURGERY, THE LOCKING SCREW DID NOT LOCK IN THE MOST DISTAL HOLE. THE SCREW WAS ONCE REMOVED, REMOVAL AND CLEANING OF SOFT TISSUE WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON EXCHANGED THE SCREW WITH ANOTHER SAME SIZE SCREW, BUT THE SCREW COULD NOT BE LOCKED. THEREFORE, RE-DRILLING WAS PERFORMED USING DRILL SLEEVE BUT THE ISSUE WAS NOT RESOLVED. ULTIMATELY, THE SURGERY WAS FINISHED WITH THE SCREW UNLOCKED AND LAG SCREW FIXATION WAS ADDED USING 3.5 MM NON-LOCKING SCREW IN ORDER TO INCREASE FRACTURE STABILITY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7567054 ↗
• MalfunctionSep 14, 2015Mechanical Problem; Positioning Problem

  IT WAS REPORTED THAT THE DISTAL HOLE OF DISTAL FIBULA PLATE AND THE SCREW COULD NOT BE LOCKED. 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 OF IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5076512 ↗
• MalfunctionSep 14, 2015Mechanical Problem; Positioning Problem

  IT WAS REPORTED THAT THE DISTAL HOLE OF DISTAL FIBULA PLATE AND THE SCREW COULD NOT BE LOCKED. 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 OF IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5075770 ↗