Arthrex® AR-9679Recalls & reported problems
Arthrex, Inc. · ANGLED REAMER, ORIENTATION SLEEVE · 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 00888867324909), received between May 5, 2025 and Nov 10, 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
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem
ON 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9675T-S AUGMENTED MGS REAMER WAS CATCHING AND DIFFICULT TO OPERATE. AN AR-9679 ANGLED REAMER ORIENTATION SLEEVE DID NOT WORK PROPERLY. AN AR-9597-20 ANGLE REAMER SLEEVE WAS GETTING CAUGHT IN A WAY IT SHOULD NOT BE. AN AR-9676T AUGMENTED REAMER LOCKING DRIVE SHAFT DID NOT LOCK. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23508985 ↗MalfunctionMay 5, 2025Break; Break
ON 04/17/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9679 ORIENTATION SLEEVE, ANGLED REAMER WAS BROKEN. THIS WAS DISCOVERED IN A CASE WITH NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960409 ↗
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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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