VARIAX 45-35015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540540461), received between Aug 15, 2018 and Feb 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2019Break

  IT WAS REPORTED THAT WHEN THE VARIAX CLAVICLE WAS REMOVED AT(B)(6)2019 BECAUSE THE BONE FUSION WAS CONFIRMED. WHEN THE SCREW WAS TRIED TO REMOVED WITH DRIVER (45-35015), IT WAS BROKEN. A SPARE DRIVER WAS NOT PREPARED AND THE OPERATION WAS INTERRUPTED FOR ABOUT 30 MIN TO ARRANGE FOR A NEW DRIVER. AFTER THAT, THE OPERATION WAS FINISHED AND THE ADVERSE EVENT DUE TO THIS EVENT NOT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374924 ↗
• MalfunctionAug 15, 2018Break

  TRIED TO PULL OUT THE FIRST SCREW MANUALLY AT THE TIME OF OPERATION OF THE NAVEL CLIPPERS NAIL, THE TIP OF THE DRIVER BROKE. FINISHED THE PROCEDURE WITH A SUBSTITUTE DRIVER. THE BROKEN TIP WAS REMOVED OUT OF PATIENT BODY.

  Patient problems: No Information

  MAUDE report 7784993 ↗