Arthrex® AR-9401-40Recalls & reported problems
Arthrex, Inc. · ECLIPSE RESECT PROTECTOR,SZ S/40.0MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867060364), received between Jun 3, 2024 and Oct 1, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2024Material Deformation; Material Deformation
ON 09/23/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06670325 THAT (QTY. 4) OF AN AR-9401-40 ARTHREX ECLIPSE RESECTION PROTECTOR, SIZE S / 40 MM, WAS STRIPPING AWAY. THIS WAS DISCOVERED DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343720 ↗MalfunctionOct 1, 2024Material Deformation; Material Deformation
ON 09/23/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 4) OF AN AR-9401-40 ARTHREX ECLIPSE RESECTION PROTECTOR, SIZE S / 40 MM, WAS STRIPPING AWAY. THIS WAS DISCOVERED DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343707 ↗MalfunctionOct 1, 2024Material Deformation; Material Deformation
ON 09/23/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT (QTY. 4) OF AN AR-9401-40 ARTHREX ECLIPSE RESECTION PROTECTOR, SIZE S / 40 MM, WAS STRIPPING AWAY. THIS WAS DISCOVERED DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343636 ↗MalfunctionOct 1, 2024Material Deformation; Material Deformation
ON 09/23/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT (QTY. 4) OF AN AR-9401-40 ARTHREX ECLIPSE RESECTION PROTECTOR, SIZE S / 40 MM, WAS STRIPPING AWAY. THIS WAS DISCOVERED DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343390 ↗MalfunctionJun 3, 2024Break; Break
IT WAS REPORTED ON 03/03/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9221AG DRILL IS BENT, AR-9628 TIP IS BROKEN, AND AR-9401-40, AR-9401-46, AR-9401-50 RESECT PROTECTOR ARE RUSTY. CASE INVOLVEMENT, NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19448894 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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