ACTIS 3010-01-060Recalls & reported problems
Depuy (Ireland) · ACTIS HIP SYSTEM BROACH SIZE 6 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295548652), received between Jun 12, 2023 and May 29, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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
- Device-Device Incompatibility8
- Break5
- Material Deformation1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information3
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE SIZE 6 ACTIS BROACH WAS DAMAGED. THE CONNECTION WAS DEFORMED AND WOULDN'T ALLOW THE CALCAR PLANER OR BROACH HANDLE TO GO ON SMOOTHLY. NO PIECES BROKE OFF; WHEN IT NOTICED THE DEVICES STOPPED BEING USED AND WERE REMOVED WITHOUT INCIDENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333339 ↗MalfunctionMay 22, 2026Scratched Material
IT WAS REPORTED THAT THE CALCAR PLANER SHAFT IS CHEWED UP ON THE INSIDE WHICH CHEWED UP THE NECK ON THE 6 ACTIS BROACH. DID NOT EFFECT PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255624 ↗MalfunctionMar 18, 2026Device-Device Incompatibility
IT WAS REPORTED THAT BROACHES WERE WORN DOWN AND HAVING AN ISSUE GETTING STUCK ON THE KINCISE BROACHES ADAPTER. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629285 ↗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 24068517 ↗MalfunctionOct 21, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT WAS FOUND OUT AFTER SURGERY.
Patient problems: Insufficient Information
MAUDE report 23347087 ↗MalfunctionAug 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH DID NOT FIT ON ADAPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22687993 ↗MalfunctionJul 9, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE CALCAR PLANAR WAS NOT GOING DOWN FLUSH ON THE ACTIS 6 FEMORAL BROACH. IT WAS BELIEVED TO BE DUE TO WEAR AROUND THE NECK/BROACH ATTACHMENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19706485 ↗MalfunctionJul 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SIZE 6 BROACHES GOT STUCK IN BROACH HANDLE. BROACH HANDLE WORKS WITH EVERY OTHER BROACH.
Patient problems: Insufficient Information
MAUDE report 19662476 ↗MalfunctionJul 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SIZE 6 BROACHES GOT STUCK IN BROACH HANDLE. BROACH HANDLE WORKS WITH EVERY OTHER BROACH.
Patient problems: Insufficient Information
MAUDE report 19662475 ↗MalfunctionApr 16, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH GETS JAMMED IN THE KINCISE BROACH ADAPTER AND IS DIFFICULT TO REMOVE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19120259 ↗MalfunctionAug 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS DIFFICULTY ASSEMBLING THE BROACH AND NECK TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17498884 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108767 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108747 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108366 ↗
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- ACTIS 3010-01-020Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-090Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-030Depuy (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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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