VARIAX 657360Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327087437), received between May 22, 2018 and May 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (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.

• MalfunctionMay 22, 2018Device Inoperable

  PRIMARY PROCEDURE, RIGHT PROXIMAL ULNA. IT WAS REPORTED THAT IN INSERTING A VARI-AX 2 CORE LOCKING SCREW INTO THE PLATE, THE SCREW WOULD NOT LOCK. THE SURGEON REMOVED THE SCREW AND TRIED ANOTHER. THE SECOND SCREW WOULD NOT LOCK. A DIFFERENT PLATE WAS IMPLANTED AND VARI-AX (NOT VARI-AX 2) LOCKING SCREWS WERE USED. THE SCREWS LOCKED INTO THE PLATE. AT THE BACK TABLE, THE HEADS OF THE FIRST 2 SCREWS APPEARED TO BE COMPROMISED. A THIRD VARI-AX 2 LOCKING SCREW WAS INSPECTED AND FOUND TO BE FREE OF DEFECT. WHEN INSERTING THE SCREW INTO THE PLATE, IT WOULD NOT LOCK. THE SCREW WAS REMOVED AND THE HEAD APPEARED TO BE COMPROMISED. A VARI-AX SCREW WAS THEN INSERTED IN THE SAME HOLE AS THE FIRST SCREWS AND IT LOCKED WITH NO ISSUE. REP REPORTED A SURGICAL DELAY OF APPROXIMATELY 30-40 MINUTES. REP REPORTED VIA PHONE THAT THE THIRD SCREW WAS DISCARDED.

  Patient problems: No Information

  MAUDE report 7531490 ↗
• MalfunctionMay 22, 2018Device Slipped

  PRIMARY PROCEDURE, RIGHT PROXIMAL ULNA. IT WAS REPORTED THAT IN INSERTING A VARI-AX 2 CORE LOCKING SCREW INTO THE PLATE, THE SCREW WOULD NOT LOCK. THE SURGEON REMOVED THE SCREW AND TRIED ANOTHER. THE SECOND SCREW WOULD NOT LOCK. A DIFFERENT PLATE WAS IMPLANTED AND VARI-AX (NOT VARI-AX 2) LOCKING SCREWS WERE USED. THE SCREWS LOCKED INTO THE PLATE. AT THE BACK TABLE, THE HEADS OF THE FIRST 2 SCREWS APPEARED TO BE COMPROMISED. A THIRD VARI-AX 2 LOCKING SCREW WAS INSPECTED AND FOUND TO BE FREE OF DEFECT. WHEN INSERTING THE SCREW INTO THE PLATE, IT WOULD NOT LOCK. THE SCREW WAS REMOVED AND THE HEAD APPEARED TO BE COMPROMISED. A VARI-AX SCREW WAS THEN INSERTED IN THE SAME HOLE AS THE FIRST SCREWS AND IT LOCKED WITH NO ISSUE. REP REPORTED A SURGICAL DELAY OF APPROXIMATELY 30-40 MINUTES. REP REPORTED VIA PHONE THAT THE THIRD SCREW WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531483 ↗