Arthrex® AR-2383Recalls & reported problems
Arthrex, Inc. · QUAD TENDON GRAFT CUTTING GUIDE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867098237), received between Dec 7, 2021 and Jul 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Break; Break
ON 06/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2383 GUIDE'S METAL LATCH BROKE WHEN THE TECH TRIED TO ATTACH DOUBLE BLADE. ISSUE DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22394173 ↗MalfunctionDec 7, 2021Material Twisted/Bent
ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(6) THAT AN AR-2383 CUTTING GUIDE WAS BENT. THIS OCCURRED DURING A CASE WHEN THE SURGEON BENT THE CUTTING GUIDE. THE CASE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO PATIENT EFFECT REPORTED. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: Insufficient Information
MAUDE report 12953203 ↗
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- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
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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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