VARIAX 703690SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327071764), received between Jul 28, 2021 and Mar 22, 2023 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2023Device Damaged Prior to Receipt by User; Inaccurate Information; Device Damaged Prior to Receipt by User; Inaccurate Information

  AS REPORTED: "A PACKET MARKED AS 2.0 DRILL AND COLOUR CODED AS SUCH WASN'T A 2.0 DRILL. CAUSED SLIGHT HARM TO WRIST OF THE PATIENT WHEN DRILLING THE SCREWS ON SHAFTS OF RADIUS PLATE AND HOLES TOO LARGE FOR SCREWS. WHEN RE-DRILLING AN ADJACENT HOLE THE PLATE COULD BE PUT BACK ON BUT AT A LESS OPTIMAL POSITION. CHECKED ALONGSIDE ANOTHER 2.0 DRILL FROM DIFFERENT PACKET AND WAS VERY DIFFERENT".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation

  MAUDE report 16591685 ↗
• InjuryFeb 24, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL BIT FRACTURE. TIP OF THE DEVICE REMAINED IN BONE, OSTEOTOMY AND RESCUE." ADDITIONALLY A 45 MINUTE DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434961 ↗
• InjuryFeb 20, 2023Device Damaged Prior to Receipt by User; Inaccurate Information; Device Damaged Prior to Receipt by User; Inaccurate Information

  AS REPORTED: "A PACKET MARKED AS 2.0 DRILL AND COLOUR CODED AS SUCH WASN'T A 2.0 DRILL. CAUSED SLIGHT HARM TO WRIST OF THE PATIENT WHEN DRILLING THE SCREWS ON SHAFTS OF RADIUS PLATE AND HOLES TOO LARGE FOR SCREWS. WHEN RE-DRILLING AN ADJACENT HOLE THE PLATE COULD BE PUT BACK ON BUT AT A LESS OPTIMAL POSITION. CHECKED ALONGSIDE ANOTHER 2.0 DRILL FROM DIFFERENT PACKET AND WAS VERY DIFFERENT".

  Patient problems: Perforation

  MAUDE report 16402737 ↗
• MalfunctionJul 28, 2021Break; Break

  WHEN DRILLING (USING A DRILL GUIDE), THE DRILL TIP BROKE AND COULD NOT BE REMOVED FROM THE BONE, AND THE SURGERY FINISHED WITH ABOUT 13 MM OF THE DRILL TIP REMAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12239271 ↗