ACTIS 2010-01-020Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 2 · 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 broach. Reports mostly describe broaches getting stuck on handles, bending or deforming, breaking, or failing to cut as expected, often due to device incompatibility. Of the 95 reports naming this device, 1 describes an injury and none describe deaths; no recalls name this device. Reports rose from 9 to 19 in the most recent 12 months compared with the prior 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
- 94
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10603295393641), received between Dec 8, 2017 and Sep 1, 2026 — classified as 1 injury, 93 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (44 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
- Device-Device Incompatibility44
- Break28
- Failure to Cut15
- Scratched Material14
- Material Deformation10
- Difficult to Advance9
- Material Twisted/Bent4
- Naturally Worn4
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Consequences Or Impact To Patient18
- Insufficient Information7
- No Code Available2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 94 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 50544208 ↗MalfunctionJul 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT BROACH GETS STUCK ON HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679182 ↗MalfunctionJun 18, 2026Material Deformation
IT WAS REPORTED THAT THE SZ 2 BROACH WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547288 ↗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 25014589 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731154 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD-STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729985 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729962 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606815 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606799 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606698 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606673 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606655 ↗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 24583544 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. IT BROKE DURING REMOVAL. NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071121 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. IT BROKE DURING REMOVAL. NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071116 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE HAD QTY:1 SIZE 6 BROACH TRUNION SNAP DURING EXTRACTION. IT BROKE DURING REMOVAL NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051509 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE HAD QTY:1 SIZE 6 BROACH TRUNION SNAP DURING EXTRACTION. IT BROKE DURING REMOVAL NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051508 ↗MalfunctionDec 12, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE ATTACHMENT PIECE SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794733 ↗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 23283352 ↗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 23283162 ↗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 23272692 ↗MalfunctionAug 1, 2025Improper or Incorrect Procedure or Method; Scratched Material; Illegible Information; Improper or Incorrect Procedure or Method; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SURGEON WAS BROACHING FOR A TOTAL HIP AND THE NURSE ACCIDENTALLY HANDED UP THE INCORRECT BROACHES AS TWO OF THEM HAD NUMBERS ON THEM THAT WERE SCRATCHED OFF AND WORN AWAY DUE TO WEAR AND TEAR OVER TIME. SURGEON WAS UPSET AS HE BROACHES A LARGER SIZE THAN HE THOUGHT AND COULD HAVE FRACTURED THE FEMUR IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SHORT DELAY IN PROCEDURE. NO PATIENT ISSUES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686279 ↗MalfunctionJun 2, 2025Break; Break
IT WAS REPORT THAT INTRAOPERATIVELY THE INSTRUMENTS´ "NOSES" BROKE OFF. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123769 ↗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 22115162 ↗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 21061757 ↗
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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