VARIAX 705133Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327399004), received between Dec 3, 2021 and Sep 30, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "1.6 DRILL BIT FRACTURED IN THE PATIENT AND NOW THE PATIENT WILL HAVE TO COME BACK TO THEATRE TO HAVE THIS REMOVED AT A LATER DATE.".

  Patient problems: Foreign Body In Patient

  MAUDE report 20333621 ↗
• MalfunctionJul 7, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN CUTTER". ADDITIONALLY A SURGICAL DELAY OF 10 MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944573 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED: "THE TIP OF A DRILL BIT BROKE OFF IN THE PATIENT'S METACARPAL. SURGEON ELECTED TO LEAVE THE TIP IN THE PATIENT'S BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 12923061 ↗