VARIAX 703696Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327069891), received between Dec 26, 2022 and Aug 20, 2024 — 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 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.

• MalfunctionAug 20, 2024Material Deformation; Material Deformation

  THE COMPANY REP REPORTED DEFECTIVE DRILL BIT TIPS. (B)(6) 2024 - ADDITIONAL INFORMATION RECEIVED: TYPE OF DEFECT: DEFORMATION THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACT. USE OF 2ND DRILL BIT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001110 ↗
• MalfunctionDec 26, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "A VARIAX DRILL 2.4MM DRILL BIT (703696) WAS USED IN A TOTAL HIP CASE AS A PILOT HOLE FOR A SUTURE PASSES. APPARENTLY UPON UNERRING THE GREATER TROCH, THE DRILL TIP SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH DRILL BIT TIP REMAINING IN PATIENT. DRILL BIT SHAFT WAS REMOVED FROM THE FIELD AND DISPOSED OF. DRILL BIT TIP WAS NOT REMOVED AS OF SURGEON RECOMMENDATION."

  Patient problems: Foreign Body In Patient

  MAUDE report 16048657 ↗