ACTIS 3010-01-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295548621), received between Jun 8, 2023 and Jan 14, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. IT BROKE DURING REMOVAL. NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071123 ↗
• MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090435 ↗
• MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090333 ↗
• MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090278 ↗