ACTIS 2010-01-050Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 5 · Class 1
Quick summary
This DePuy ACTIS surgical broach has 232 adverse event reports, including 5 injuries and no deaths. The reports mostly describe broaches breaking, parts not fitting together, and scratched or bent metal. 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
- 235
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 10603295393672), received between May 4, 2018 and Sep 1, 2026 — classified as 5 injuries, 230 malfunctions.
The most frequently reported specific device problem is “Break” (102 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break102
- Device-Device Incompatibility94
- Scratched Material27
- Material Deformation26
- Failure to Cut12
- Naturally Worn11
- Difficult to Advance9
- Material Twisted/Bent9
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- No Consequences Or Impact To Patient36
- Insufficient Information31
- Not Applicable16
- No Code Available14
- Unspecified Tissue Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Notching1
Recent adverse event reports
The 25 most recent of 235 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 50545147 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408637 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379540 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379186 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356435 ↗MalfunctionMay 28, 2026Break
IT WAS REPORTED THAT THE POST BROKE OFF THE TOP OF THE SIZE 5 ACTIS BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322067 ↗MalfunctionMay 26, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT 5 BROACH THE TIP IS BENT AND WON'T CONNECT TO BROACH HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277393 ↗MalfunctionMay 15, 2026Break; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT T HANDLE WAS CRACKED, BROACHES WERE CHIPPED/SCRATCHED AND DID NOT FIT INTO BROACH HANDLES. THE CUP IMPACTOR SCREW WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185977 ↗MalfunctionMay 12, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY. MALE END OF BROACH IS BENT AND WON'T ACCEPT NECK TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149928 ↗MalfunctionApr 28, 2026Material Deformation; Scratched Material
IT WAS REPORTED DURING MDRD INSPECTION, SEVERAL ACTIS BROACHES WERE FOUND TO BE DAMAGED. THE BROACHES HAD LARGE DENTS AND CURLING OF THE METAL ON THE COMPACTION TEETH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014701 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT SIZE 5 ACTIS BROACH BROKE OFF AT THE CONNECTION LEAVING A SMALL NUB WHILE IN PT- BROACH WAS ABOUT TO BE REMOVED BEFORE STEM IMPLANTATION. BROACH WAS REMOVED WITH OSTEOTOMES AND VICEGRIPS WITHOUT MUCH ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754096 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734358 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734148 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24733537 ↗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 24591466 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT THERE WAS A BROKEN ACTIS BROACH SIZE 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312939 ↗MalfunctionFeb 10, 2026Break
IT WAS REPORTED THAT THERE WAS BROKEN BROACHES/T HANDLE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305547 ↗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 24068509 ↗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 24068508 ↗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 24068503 ↗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 24068474 ↗MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT BROACH JUNCTION SNAPPED FOR BOTH SIZES 4 AND 5 WHILE IMPACTING WITH INCISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019120 ↗MalfunctionNov 21, 2025Break; Break
IT WAS REPORTED THAT SZ 5 ACTIS BROACH BROKE INTO TWO PIECES AT ATTACHMENT POINT DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621732 ↗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 23283500 ↗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 23283409 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 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
- CORAIL 952210500FDepuy (Ireland) · BROACH157 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.