ACTIS 2010-01-100Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 10 · 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 instrument used to shape the femur bone during hip replacement. The 61 reports mostly describe broaches breaking during surgery, sometimes into multiple pieces that had to be removed, along with difficulty advancing the instrument, failure to cut, and compatibility problems with other devices. No deaths or injuries are reported. There are no recalls naming 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
- 62
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295393726), received between May 4, 2018 and Sep 9, 2026 — classified as 62 malfunctions.
The most frequently reported specific device problem is “Break” (20 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
- Break20
- Device-Device Incompatibility18
- Failure to Cut12
- Difficult to Advance10
- Scratched Material4
- Appropriate Device Problem Term/Code Not Available3
- Fitting Problem3
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient15
- Insufficient Information5
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break; Device-Device Incompatibility
It was reported that the Broaches were broke during a case. Surgeon needed to order all new sets of broaches with the new Design in case this happens again.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689155 ↗MalfunctionAug 20, 2026Break; Entrapment of Device
It was reported that during a Total Hip Replacement surgical procedure it was observed that the broaches broke and could not be extracted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50346130 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742029 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742004 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741906 ↗MalfunctionMar 13, 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 24591477 ↗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 24579464 ↗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 24579455 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION AND BROKE INTO MULTIPLE PIECES DURING REMOVAL. ALL PARTS WERE RETRIEVED, AND THE SURGEON REQUESTED SWAPPING ALL BROACHES FOR SLOTTED BROACHES TO EASE FUTURE EXTRACTIONS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060276 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION AND BROKE INTO MULTIPLE PIECES DURING REMOVAL. ALL PARTS WERE RETRIEVED, AND THE SURGEON REQUESTED SWAPPING ALL BROACHES FOR SLOTTED BROACHES TO EASE FUTURE EXTRACTIONS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060275 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION AND BROKE INTO MULTIPLE PIECES DURING REMOVAL. ALL PARTS WERE RETRIEVED, AND THE SURGEON REQUESTED SWAPPING ALL BROACHES FOR SLOTTED BROACHES TO EASE FUTURE EXTRACTIONS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060272 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION AND BROKE INTO MULTIPLE PIECES DURING REMOVAL. ALL PARTS WERE RETRIEVED, AND THE SURGEON REQUESTED SWAPPING ALL BROACHES FOR SLOTTED BROACHES TO EASE FUTURE EXTRACTIONS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060264 ↗MalfunctionOct 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS BROACHES NEED TO BE REPLACED. THERE WERE SEVERE STRESS RINGS ON THEM WHERE THEY ATTACH TO BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM. WHEN THEY BREAK IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT. (B)(4) IS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277850 ↗MalfunctionOct 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS BROACHES NEED TO BE REPLACED. THERE WERE SEVERE STRESS RINGS ON THEM WHERE THEY ATTACH TO BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM. WHEN THEY BREAK IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT. (B)(4) IS RELATED TO(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277824 ↗MalfunctionOct 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS BROACHES NEED TO BE REPLACED. THERE WERE SEVERE STRESS RINGS ON THEM WHERE THEY ATTACH TO BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM. WHEN THEY BREAK IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277807 ↗MalfunctionJun 23, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT BROACH WON'T SEAT ON THE HANDLE COMPLETELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22308275 ↗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 22114695 ↗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 22114550 ↗MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE EXTRACTOR WOULD NOT FIT INTO THE OLD BROACHES SO THEY SWAPPED OUT FOR NEW ONES.
Patient problems: Insufficient Information
MAUDE report 21056603 ↗MalfunctionOct 21, 2024Break; Naturally Worn; No Apparent Adverse Event; Break; Naturally Worn; No Apparent Adverse Event
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DAMAGED AND REQUIRE REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20492967 ↗MalfunctionAug 20, 2024Device-Device Incompatibility; Device-Device Incompatibility
BROACHES DO NOT FIT SMOOTHLY INTO BRASH HANDLES OR KINCISE BROACH ADAPTERS. DIFFERENT BROACH HANDLES AND ADAPTERS WERE ATTEMPTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006074 ↗MalfunctionJan 18, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TRAIL NECKS DO NOT GO ALL THE WAY DOWN. IT APPEARS THE ATTEMPT PIECE IS BENT.
Patient problems: Insufficient Information
MAUDE report 18534006 ↗MalfunctionOct 13, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE ACTIS SIZE 10 BROACH WAS INSERTED INTO THE FEMUR VIA KINCISE. REMOVAL OF THE BROACH FROM FEMUR WAS ATTEMPTED USING KINCISE, AN EXTRA CURVED BROACH HANDLE, AND A DOUBLE OFFSET BROACH HANDLE. AFTER SUCCESSFUL EXTRACTION OF BROACH, IMPERFECTIONS IN THE NECK/ TRUNION AREA OF BROACH WERE PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17930064 ↗MalfunctionOct 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES, AND ALSO A MISMATCH BETWEEN OUR TRIAL HEADS TO OUR REAL HEADS. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17917546 ↗MalfunctionOct 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES, AND ALSO A MISMATCH BETWEEN OUR TRIAL HEADS TO OUR REAL HEADS. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17917539 ↗
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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