Agili-C Mini Disposable Toolset MINI-DSRecalls & reported problems
Cartiheal (2009) Ltd · Agili-C Mini Disposable Toolset · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290019087045), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Fracture; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT, DURING SURGERY, THE K-WIRE OF THE ARAGONITE DISPOSABLE INSTRUMENT KIT BROKE WHEN REMOVING THE DRILL BIT AND DRILL SLEEVE. THE SURGEON ADMITTED THAT SHE ¿LET HER HAND DROP¿ TOO MUCH AND LOST HER PERPENDICULARITY. THE BROKEN PIECE WAS EASILY REMOVED USING THE PIN-DRIVER. THE PROCEDURE WAS RESUMED WITHOUT INCIDENT, AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP PRODUCT. FOLLOWING THE REPLACEMENT OF THE K-WIRE, THE SURGEON MAINTAINED PROPER PERPENDICULARITY FOR THE REMAINDER OF THE SURGERY AND THE CASE WAS COMPLETED WITHOUT INCIDENT. PATIENT WAS NOT HARMED. THE SURGEON WAS EXTREMELY SATISFIED WITH THE SURGICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093018 ↗
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- ACTIS 3010-01-070Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
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- 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 3010-01-090Depuy (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 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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