ACTIS 2010-01-120Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 12 · 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 enlarge the bone before implant placement. The 52 reports mostly describe the broach breaking during use, failing to cut properly, or being difficult to advance, along with some twisted metal and cases where it did not fit with other instruments. Most reports mention no harm to the patient; there are no deaths and no injuries. No recalls name this device. Reports rose from 4 in the previous 12 months to 15 in the most recent 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
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295421122), received between May 7, 2018 and Sep 9, 2026 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Break” (21 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
- Break21
- Failure to Cut12
- Difficult to Advance9
- Device-Device Incompatibility8
- Material Twisted/Bent3
- Naturally Worn2
- Nonstandard Device2
- Scratched Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient12
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 53 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 50689256 ↗MalfunctionAug 20, 2026Break; Entrapment of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50346132 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743250 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742968 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742600 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED MULTIPLE VERSION 1 AND 2 BROACHES BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681029 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED MULTIPLE VERSION 1 AND 2 BROACHES BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674697 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED MULTIPLE VERSION 1 AND 2 BROACHES BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674655 ↗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 24597833 ↗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 24590472 ↗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 24590403 ↗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 24590373 ↗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 24060268 ↗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 24060267 ↗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 24060266 ↗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 24060259 ↗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 22114645 ↗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 22114527 ↗MalfunctionJan 13, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL NECK INSERTION POST ON BROACH BROKE OFF DURING CASE. THERE WAS NO DELAY TO CASE AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21144137 ↗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 21056552 ↗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 20493061 ↗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 17917515 ↗MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17905570 ↗MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17905484 ↗MalfunctionMay 26, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009729 ↗
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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