ACTIS 2010-01-090Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 9 · Class 1
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Actis broach, a surgical instrument used to prepare the hip bone for implant fitting, is the subject of 73 adverse event reports, with no deaths and no injuries. Reports mostly describe the broach tip or trunnion breaking off so the instrument cannot be removed, along with difficulty advancing it, not cutting, and scratched or deformed material. Most reports list no effect on the patient. No recalls name this device, and reports rose from 8 in the prior12 months to 18 in the last 12 months.
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
- 73
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10603295393719), received between May 4, 2018 and Sep 9, 2026 — classified as 73 malfunctions.
The most frequently reported specific device problem is “Break” (26 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
- Break26
- Device-Device Incompatibility19
- Failure to Cut15
- Difficult to Advance11
- Scratched Material6
- Material Deformation3
- Material Twisted/Bent3
- Naturally Worn3
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient15
- Insufficient Information3
- Not Applicable1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break; Device-Device Incompatibility
It was reported that the impacted product had an unknown allegation. New actis broaches needed to complete the set.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689141 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379033 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379031 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741175 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741157 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741097 ↗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 24598106 ↗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 24598093 ↗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 24594511 ↗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 24591073 ↗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 24583555 ↗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 24580931 ↗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 24579018 ↗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 24068780 ↗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 24068776 ↗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 24068774 ↗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 24068749 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT ONE OF THE TEETH ON THE SIZE 6 ACTIS BROACHES CHIPPED ON A RETRACTOR DURING FEMORAL PREP. THERE WAS NO DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583980 ↗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 23279955 ↗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 23272762 ↗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 22114817 ↗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 22114721 ↗MalfunctionApr 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SIZE 8 AND 9 BROACHES WERE DIFFICULT TO REMOVE FROM BROACH HANDLE. THERE WAS FEAR OF TRUNION BREAKING OFF WHILE IMPACTING BROACH. THERE WAS NO ADVERSE EFFECT ON THE SURGERY AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748448 ↗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 21061766 ↗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 WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892907 ↗
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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