Arthrex® AR-9597-25Recalls & reported problems
Arthrex, Inc. · ANGLED REAMER SLEEVE, 25° · Class 1
Data updated Oct 18, 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 00888867343467), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
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.
MalfunctionApr 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT AND AN AR-9597-25 ANGLED REAMER SLEEVE HAD AN ISSUE. WHILE PREFORMING AN AUGMENTED RTSA, THE 25 DEGREE REAMER AND DRIVE SHAFT BECAME COLD WELDED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078814 ↗
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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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