ACTIS 2010-01-005Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 0 · Class 1
Quick summary
This DePuy Actis broach is a surgical bone instrument used to shape the femur for a hip replacement. Most of the 57 reports describe the broach breaking during surgery, sometimes in two or more pieces that could not be removed and had to be taken out with another instrument, along with broaches not fitting their handles and scratched or bent surfaces. There are no deaths and no injuries. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295393627), received between May 3, 2018 and Sep 1, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
- Break27
- Device-Device Incompatibility25
- Failure to Cut7
- No Apparent Adverse Event6
- Material Twisted/Bent5
- Scratched Material4
- Appropriate Device Problem Term/Code Not Available2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient12
- Insufficient Information4
- No Code Available1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Break; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544055 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT ACTIS BROACH SZ 0 AND ACTIS BROACH SZ 1 WERE INVOLVED IN AN INTRAOPERATIVE EVENT WHERE THE TRUNNION OF THE BROACH COULD NOT BE EXTRACTED IF IT BROKE, WITH THE DEVICE DESCRIBED AS BREAKING INTO TWO OR MORE PIECES. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551887 ↗MalfunctionMay 15, 2026Break; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE T HANDLE WAS CRACKED, BROACHES WERE CHIPPED/SCRATCHED AND DID NOT FIT INTO BROACH HANDLES. THE CUP IMPACTOR SCREW WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185907 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730317 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729645 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729572 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE BROACH UNABLE TO EXTRACT WITH BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638052 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE BROACH UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638029 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE BROACH UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638003 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE BROACH UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637988 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE BROACH UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637953 ↗MalfunctionMar 13, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24598542 ↗MalfunctionMar 13, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24598534 ↗MalfunctionMar 13, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592722 ↗MalfunctionMar 13, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592698 ↗MalfunctionMar 13, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592662 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THAT BROACHES ARE BROKEN INTO TWO PIECES. NO ADDITIONAL FRAGMENTS. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583532 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE HAD QTY:1 SIZE 6 BROACH TRUNION SNAP 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 24051555 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE HAD QTY:1 SIZE 6 BROACH TRUNION SNAP 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 24051543 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE HAD QTY:1 SIZE 6 BROACH TRUNION SNAP 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 24051540 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE HAD QTY:1 SIZE 6 BROACH TRUNION SNAP 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 24051534 ↗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 23272679 ↗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 22115234 ↗MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BROACHES DID NOT BREAK BUT EXTRACTOR WILL NOT FIT INTO THESE. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21061746 ↗MalfunctionDec 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE OLD ACTIS BROACHES WERE SWAPPED OUT WITH NEW ONES. THERE WERE NO PIECES BROKEN OFF AND NEW BROACHES HAVE EXTRA SLOT FOR EXTRACTION. THERE WERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892647 ↗
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.