Arthrex® AR-9597-15Recalls & reported problems
Arthrex, Inc. · ANGLED REAMER SLEEVE, 15° · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867343443), received between Apr 23, 2024 and Aug 15, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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
- Physical Resistance/Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/30/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-15 ANGLE REAMER SLEEVE AND AN AR-9676 ANGLE REARMER DRIVE SHAFT WERE WELDED TOGETHER. THE CASE CONTINUED AND WAS COMPLETED SUCCESSFULLY WITH BACKUP INSTRUMENTS. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19993935 ↗MalfunctionJun 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED ON 03/02/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9597-15 ANGLED REAMER SLEEVE WAS CATCHING THE AR-9676 REAMER SHAFT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567884 ↗MalfunctionApr 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT WHILE USING THE AVL REAMERS, SOMEHOW THE REAMER SHAFT GOT COLD WELDED TO THE ANGLED REAMER SLEEVE. SURGEON WAS UNABLE TO UNABLE TO COMPLETE THE AUGMENT AND SWITCHED TO A STANDARD VL. ALSO, THE 4.5 DRILL GOT STUCK IN SMALL DRILL GUIDE. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19164415 ↗
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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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