ACTIS 2010-01-010Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 1 · Class 1
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ACTIS broach is a surgical tool used to shape bone for a hip implant. Many of its 88 reports describe broaches breaking, and some describe a broken piece stuck in the patient or failure to cut. The reports include 1 injury and no deaths. Reports rose from 7 in the prior 12 months to 21 in the last 12 months. 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
- 87
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10603295393634), received between May 3, 2018 and Sep 1, 2026 — classified as 1 injury, 86 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (35 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility35
- Break29
- Failure to Cut12
- Difficult to Advance9
- Material Twisted/Bent7
- Scratched Material7
- No Apparent Adverse Event6
- Fitting Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient24
- Insufficient Information3
- Limb Fracture1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 87 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 50544147 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24732460 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731807 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731782 ↗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 24638268 ↗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 24638242 ↗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 24638207 ↗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 24638119 ↗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 24638086 ↗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 24598813 ↗MalfunctionMar 13, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24598613 ↗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 24593308 ↗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 24593198 ↗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 24593093 ↗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 24583535 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THE BROACH WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575576 ↗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 24051533 ↗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 24051532 ↗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 24051530 ↗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 24051523 ↗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 23283381 ↗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 23272686 ↗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 22115223 ↗MalfunctionMay 26, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ACTIS BROACH WON¿T SEPARATE FROM THE KINCISE ANTERIOR BROACH ADAPTOR. PATIENT NOT AFFECTED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084397 ↗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 21061750 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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