ACTIS 3010-01-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295548645), received between Jan 18, 2023 and Sep 22, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that the size 5 actis broach snapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853258 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE 5 ACTIS BROACH WAS GETTING STUCK TO KINCISE ATTACHMENT AND NECK TRIAL WOULDN¿T COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605985 ↗
• MalfunctionOct 10, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE ARE SEVERE STRESS RINGS ON ACTIS BROACHES WHERE THEY ATTACH TO BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM AND WHEN THEY BREAK IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23272708 ↗
• MalfunctionNov 7, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PROXIMAL PORTION OF THE SIZE 5 ACTIS BROACH WAS SLIGHTLY BENT, NOT ALLOWING THE NECK TRIALS TO SIT PROPERLY ON THE TRIAL BROACH.

  Patient problems: Insufficient Information

  MAUDE report 20630371 ↗
• MalfunctionJul 9, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CALCAR PLANAR WAS NOT GOING DOWN FLUSH ON THE ACTIS 5 FEMORAL BROACH. IT WAS BELIEVED TO BE DUE TO WEAR AROUND THE NECK/BROACH ATTACHMENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706616 ↗
• MalfunctionMar 6, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: THERE WAS NO SPECIFIC ALLEGATIONS OF DEFICIENCY AGAINST THE FOUR OTHER SIZE 5 BROACHES THAT WERE RETURNED, NOT THAT WE KNOW OF.

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

  MAUDE report 18844488 ↗
• MalfunctionSep 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON WAS REAMING A CALCAR REAMER OVER THE BROACH. NOTHING UNUSUAL HAPPENED DURING THE REAMING , BUT WHEN THE SURGEON FINISHED REAMING, THE CALCAR REAMER WOULD NOT COME OFF THE BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669811 ↗
• MalfunctionAug 2, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE BROACHES ARE ¿STICKING¿ IN THE HANDLES AND A FEW SIZE 5 HAVE ACTUALLY BROKEN IN SPD WHEN TRYING TO SEPARATE FROM THE HANDLES. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440058 ↗
• MalfunctionAug 1, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE BROACHES ARE ¿STICKING¿ IN THE HANDLES AND A FEW SIZE 5 HAVE ACTUALLY BROKEN IN SPD WHEN TRYING TO SEPARATE FROM THE HANDLES. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434976 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108762 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108518 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108373 ↗
• MalfunctionMar 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 5 ACTIS BROACH WAS CATCHING ON THE BROACH HANDLE. IT DIDN¿T SMOOTHLY GO ON AND OFF THE HANDLE. THE CONNECTION WAS INSPECTED AND CAN¿T IDENTIFY ANYTHING SPECIFICALLY WRONG WITH IT. SO, IT WAS PULLED OUT FROM TRAY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555678 ↗
• MalfunctionJan 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH THE BROACHES WOULD NOT FIT ONTO KINCISE ADAPTORS. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196905 ↗