ACTIS 3010-01-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295548638), received between Jun 8, 2023 and Mar 18, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT BROACHES WERE WORN DOWN AND HAVING AN ISSUE GETTING STUCK ON THE KINCISE BROACHES ADAPTER. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631180 ↗
• 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 24071127 ↗
• MalfunctionAug 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 4 BROACH WOULD NOT CONNECT PROPERLY TO THE THUMPER BROACH ATTACHMENT OR THE MATTE BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840239 ↗
• MalfunctionNov 11, 2024Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT TRUNNION ON SZ.4 ACTIS BROACH WAS DAMAGED AND IT WAS DIFFICULT TO PLACE NECK SEGMENT IN BROACH FOR TRIALING.

  Patient problems: Insufficient Information

  MAUDE report 20653898 ↗
• MalfunctionMay 7, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 19258119 ↗
• MalfunctionNov 27, 2023Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SPD NOTICED RUST-LIKE MATERIAL ON AN ACTIS BROACH. THE DEVICE WAS NOT USED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210495 ↗
• MalfunctionNov 3, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT BROACH WAS STICKING TO HANDLE. THERE WERE SCUFFS ON NECK. PATIENT WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065511 ↗
• MalfunctionSep 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WERE BLACK STAINS ON THE SIZE 4 ACTIS BROACH. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777527 ↗
• MalfunctionJun 26, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE BROACH WAS STUCK TO HANDLE AND IT WAS BELIEVE THAT THE CONNECTING PORTION IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199669 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108374 ↗
• MalfunctionJun 12, 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 17108192 ↗
• 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 17090329 ↗