ACTIS 2010-01-060Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 6 · 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 hip surgery instrument used to shape the bone for an implant. Many of its 188 reports describe the broach breaking, sometimes while in the patient, and some describe parts that did not fit other instruments. There are 6 injury reports and no deaths. No recalls name this device. Reports rose from 19 in the year before to 27 in the latest year.
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
- 186
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10603295393689), received between May 4, 2018 and Sep 15, 2026 — classified as 6 injuries, 180 malfunctions.
The most frequently reported specific device problem is “Break” (83 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
- Break83
- Device-Device Incompatibility72
- Material Deformation19
- Failure to Cut15
- Scratched Material12
- Difficult to Advance10
- Material Twisted/Bent10
- Material Integrity Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions129
- No Consequences Or Impact To Patient26
- Insufficient Information20
- No Code Available8
- Not Applicable4
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device-Device Incompatibility
It was reported that the broach did not stay attached to the handle. The end of the broach had been marked with a permanent marker to demonstrate the issue. The issue did not occur during surgery. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775353 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496916 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356470 ↗MalfunctionApr 2, 2026Break
IT WAS REPORTED THAT THE ACTIS BROACH WAS BROKEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769715 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737354 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737185 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734817 ↗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 24598230 ↗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 24594730 ↗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 24591764 ↗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 24591716 ↗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 24591707 ↗MalfunctionMar 13, 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 24590244 ↗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 24586902 ↗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 24579293 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT SIZE 6 ACTIS BROACH BROKE DURING SURGERY, ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570786 ↗MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT THE BROACH CONNECTION TIP WAS BROKEN. INTO TWO PIECES. CAUSED A 10 MINUTE DELAY TO GET THE BROACH OUT. ALL PIECES RECOVERED. NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534011 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT THE ACTIS BROACH POST BROKE OFF DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512244 ↗MalfunctionJan 29, 2026Break
ADDITIONAL INFORMATION RECEIVED STATES THAT IT WAS BROKEN NEAR THE NECK OF THE BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24214938 ↗MalfunctionJan 27, 2026Break
DURING A PROCEDURE, THE CONNECTOR TIP FOR SIZE 6 ACTIS BROACH BROKE OFF. BROKEN ITEM WAS REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188559 ↗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 24068565 ↗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 24068506 ↗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 24068476 ↗MalfunctionJan 7, 2026Break; Scratched Material
IT WAS REPORTED THAT SIZE 6 ACTIS BROACH WAS NOTICEABLY SCRAPED/GOUGED ON MEDIAL SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993674 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE BROACH BROKE OFF DURING BROACH EXTRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831460 ↗
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 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 reports
- CORAIL 952210500FDepuy (Ireland) · BROACH157 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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