ACTIS 2010-01-080Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 8 · Class 1
Quick summary
This DePuy ACTIS broach is a surgical tool used to prepare the thigh bone during hip replacement. Many of its 108 reports describe the broach breaking, sometimes with the tip snapping off inside the femur. Some describe broaches that were damaged or incompatible with other devices. The reports mention no deaths and 6 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
- 108
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10603295393702), received between May 4, 2018 and Sep 1, 2026 — classified as 5 injuries, 103 malfunctions.
The most frequently reported specific device problem is “Break” (43 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
- Break43
- Device-Device Incompatibility34
- Failure to Cut15
- Scratched Material12
- Difficult to Advance9
- Material Deformation9
- Material Twisted/Bent8
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- No Consequences Or Impact To Patient18
- Insufficient Information10
- Not Applicable6
- Unspecified Tissue Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 25 most recent of 108 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 50546049 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379478 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379336 ↗MalfunctionJun 24, 2026Break
IT WAS REPORTED THAT THE TIP OF THE SIZE 8 BROACH BROKE OFF OF BROACH HANDLE INSIDE THE PATIENT FEMUR DURING CASE. SURGEON WAS ABLE TO REMOVE WITH MINIMAL DELAY. NO PATIENT HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610058 ↗MalfunctionApr 28, 2026Material Deformation; Scratched Material
IT WAS REPORTED DURING MDRD INSPECTION, SEVERAL ACTIS BROACHES WERE FOUND TO BE DAMAGED. THE BROACHES HAD LARGE DENTS AND CURLING OF THE METAL ON THE COMPACTION TEETH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014911 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741074 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741046 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735873 ↗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 24598134 ↗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 24598118 ↗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 24591173 ↗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 24590972 ↗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 24583548 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THAT THIS FACILITY HAD MULTIPLE VERSION 1 AND 2 BROACHES BREAK AND WERE REQUESTING ALL OF THEIR CONSIGNED BROACHES BE SWAPPED OUT FOR VERSION 3 TO AVOID FURTHER BREAKAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580822 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THAT THIS FACILITY HAD MULTIPLE VERSION 1 AND 2 BROACHES BREAK AND WERE REQUESTING ALL OF THEIR CONSIGNED BROACHES BE SWAPPED OUT FOR VERSION 3 TO AVOID FURTHER BREAKAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579152 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. ALL PARTS WERE RETRIEVED. ALL BROACHES WERE SWAPPED FOR SLOTTED BROACHES FOR EASE OF EXTRACTION AS PER SURGEON REQUEST. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24068772 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. ALL PARTS WERE RETRIEVED. ALL BROACHES WERE SWAPPED FOR SLOTTED BROACHES FOR EASE OF EXTRACTION AS PER SURGEON REQUEST. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24068769 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. ALL PARTS WERE RETRIEVED. ALL BROACHES WERE SWAPPED FOR SLOTTED BROACHES FOR EASE OF EXTRACTION AS PER SURGEON REQUEST. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24068756 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. ALL PARTS WERE RETRIEVED. ALL BROACHES WERE SWAPPED FOR SLOTTED BROACHES FOR EASE OF EXTRACTION AS PER SURGEON REQUEST. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24068747 ↗MalfunctionOct 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS BROACHES NEEDED TO BE REPLACED. THERE WERE SEVERE STRESS RINGS ON THEM WHERE THEY ATTACH TO THE BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM. WHEN THEY BREAK, IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279952 ↗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 23272747 ↗MalfunctionAug 15, 2025Break; Break
IT WAS REPORTED THAT THE BROACH POST WAS BROKEN OFF OF THE SIZE 8 ACTIS BROACH WHILE ATTEMPTING TO REMOVE THE BROACH FROM THE FEMUR USING THE MATTA ANTERIOR BROACH HANDLE. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817499 ↗MalfunctionJun 2, 2025Break; Break
IT WAS REPORTED THAT BROACH PEG THAT INTERFACES WITH THE KINCISE BROKE OFF WHILE BROACHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123376 ↗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 22114828 ↗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 22114763 ↗
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.