ACTIS 3010-01-080Recalls & reported problems
Depuy (Ireland) · ACTIS HIP SYSTEM BROACH SIZE 8 · Class 2
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295548676), received between Jun 8, 2023 and Mar 13, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 Incompatibility4
- Break3
- No Apparent Adverse Event2
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 24594530 ↗MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT IS DAMAGED AND WILL NOT FIT KINCISE IMPACTOR.
Patient problems: Insufficient Information
MAUDE report 20531959 ↗MalfunctionAug 21, 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 20013185 ↗MalfunctionAug 15, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE TRUNNION IS WORN, WILL NOT CONNECT TO KINCISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19992480 ↗MalfunctionJul 28, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
ADDITIONAL INFORMATION RECEIVED. A. DID THE INSTRUMENT BROKE INTO TWO OR MORE PIECES? IF YES, WERE THE FRAGMENTS REMOVED FROM THE PATIENT? THE BROACH DID NOT BREAK INTO PIECES. B. WHY WON'T THE SIZE 8 ACTIS BROACH WOULD NOT FIT INTO THE KINCISE ANTERIOR ADAPTER? EXACT ALLEGATION/MALFUNCTION OF THE BROACH. THE PROXIMAL ATTACHMENT POINT FOR THE BROACH WITH THE HANDLE WAS WARPED SOMEHOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415309 ↗MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17089676 ↗MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17089598 ↗
Other Instruments designed for press-fit osteochondral implants devices
- ACTIS 3010-01-060Depuy (Ireland) · Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-050Depuy (Ireland) · Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-040Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-070Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-010Depuy (Ireland) · Instruments designed for press-fit osteochondral implants5 reports
- ACTIS 3010-01-020Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-030Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-090Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 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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