ACTIS 3010-01-070Recalls & reported problems
Depuy (Ireland) · ACTIS HIP SYSTEM BROACH SIZE 7 · Class 2
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295548669), received between Jan 18, 2023 and May 11, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Device-Device Incompatibility5
- Material Deformation4
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Material Deformation
IT WAS REPORTED THAT THERE WAS BROACH DENTED BY THE RETRACTOR. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136387 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT SIZE 7 ACTIS BROACH CONNECTION IS BROKEN. OFFSET BROACH HANDLE MAY HAVE IMPACTED THE STEM AT WEIRD ANGLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24191422 ↗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 24068751 ↗MalfunctionMar 10, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED: THE TIP OF THE BROACH APPEARED WORN AND BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21563416 ↗MalfunctionNov 15, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING SURGERY THE MALE ADAPTER PART OF THE SIZE 7 ACTIS BROACH BENT AND BECAME STUCK IN THE BROACH ADAPTER FOR KINCISE. A SECOND SET OF ACTIS BROACH TRIALS WAS OPENED AND USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20698463 ↗MalfunctionAug 27, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE BROACH WILL NOT FIT WELL ON BROACH HANDLES. ATTACHMENT PIECE IS BENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20075030 ↗MalfunctionFeb 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DEVICE WAS RECEIVED WITHOUT ALLEGATION. VISUAL EXAM OF THE RECEIVED DEVICE FOUND THE BROACH POST IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18669668 ↗MalfunctionJan 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WOULD NOT ADAPT TO KINCISE ADAPTORS AND GIVES INTERFERENCE WITH THE CALCAR PLANER. THERE WAS NO ISSUES. NO ADVERSE EVENTS REPORTED. THERE WAS NO SURGICAL DELAY, NOTHING FURTHER TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551529 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108755 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108746 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108735 ↗MalfunctionJan 18, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BOTH THE BROACHES WOULD NOT FIT ONTO KINCISE ADAPTORS.THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16196903 ↗
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 3010-01-080Depuy (Ireland) · Instruments designed for press-fit osteochondral implants7 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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