ACTIS 2010-01-110Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 11 · Class 1
Quick summary
This DePuy ACTIS broach is a surgical bone-cutting instrument used to shape bone during operations. Reports mostly describe the tool breaking during use, failing to cut properly, or being hard to advance, and sometimes breaking so that a piece could not be removed. There are 44 reports, with no deaths and no injuries, and most mention no effect on the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295393733), received between May 4, 2018 and Sep 9, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Break” (15 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.
Reports received per month
Most reported problems
Device problems
- Break15
- Failure to Cut11
- Difficult to Advance9
- Device-Device Incompatibility8
- Material Twisted/Bent3
- Appropriate Device Problem Term/Code Not Available2
- Fitting Problem2
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient11
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break; Device-Device Incompatibility
It was reported that the Broaches were broke during a case. Surgeon needed to order all new sets of broaches with the new Design in case this happens again.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689223 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742396 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742336 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742287 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED MULTIPLE VERSION 1 AND 2 BROACHES BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680931 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED MULTIPLE VERSION 1 AND 2 BROACHES BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674775 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED MULTIPLE VERSION 1 AND 2 BROACHES BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674562 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594348 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594332 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594330 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590256 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE ACTIS HIP BROACHES POSTS SHEARED OFF AND DO NOT HAVE THE T-SLOT FOR EXTRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114657 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE ACTIS HIP BROACHES POSTS SHEARED OFF AND DO NOT HAVE THE T-SLOT FOR EXTRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114650 ↗MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE EXTRACTOR WOULD NOT FIT INTO THE OLD BROACHES SO THEY SWAPPED OUT FOR NEW ONES.
Patient problems: Insufficient Information
MAUDE report 21056741 ↗MalfunctionOct 21, 2024Break; Naturally Worn; No Apparent Adverse Event; Break; Naturally Worn; No Apparent Adverse Event
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DAMAGED AND REQUIRE REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493069 ↗MalfunctionOct 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES, AND ALSO A MISMATCH BETWEEN OUR TRIAL HEADS TO OUR REAL HEADS. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17917551 ↗MalfunctionOct 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES, AND ALSO A MISMATCH BETWEEN OUR TRIAL HEADS TO OUR REAL HEADS. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17917540 ↗MalfunctionOct 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES, AND ALSO A MISMATCH BETWEEN OUR TRIAL HEADS TO OUR REAL HEADS. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17917529 ↗MalfunctionMay 26, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009652 ↗MalfunctionMar 9, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511875 ↗MalfunctionFeb 24, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL. NEED TO REPLACE 5 CONSIGNMENT SETS, SIZES 0- 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16434748 ↗MalfunctionDec 21, 2022Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE BROACHES ARE SITTING PROUD. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16025809 ↗MalfunctionDec 21, 2022Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE BROACHES ARE SITTING PROUD. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16025056 ↗MalfunctionJul 26, 2022Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE BROACHES ARE SITTING PROUD. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103792 ↗MalfunctionJul 26, 2022Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE BROACHES ARE SITTING PROUD. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103725 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.