VariAx 656432Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327068986), received between Sep 12, 2019 and Feb 17, 2020 — 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.

• MalfunctionFeb 17, 2020Fracture; Fracture

  AS REPORTED: "DRILL TIP BROKE OFF WHILE DRILLING 5TH OUT OF 6 HOLES, VARIAX 2 SCREW HEAD CAME OFF WHEN FINAL TIGHTENING INTO PLATE, AND AXSOS SCREW HEAD BROKE WHILE IMPLANTING." REP REPORTED THAT THE PROCEDURE WAS A REVISION DUE TO "NONUNION OF DISTAL FEMUR FRACTURE." WITH COMPLICATING CONDITION "ABOVE IMPLANT FEMUR SHAFT FRACTURE ALONG WITH NONUNION."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9718099 ↗
• MalfunctionSep 12, 2019Break; Detachment of Device or Device Component

  PRIMARY LISFRANC PROCEDURE, RIGHT FOOT. IT WAS REPORTED THAT WHEN THE NON-LOCKING SCREW WAS SEATED IN THE PLATE, THE SURGEON WAS USING THE SCREW TO COMPRESS THE FRACTURE WHEN THE HEAD OF THE SCREW BROKE OFF. THE SCREW HEAD WAS ABLE TO BE RETRIEVED, THE REST OF THE SCREW WAS LEFT IN THE PATIENT. ANOTHER SCREW WAS IMPLANTED UNDER THE PREVIOUS SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9010990 ↗