Arthrex® AR-9675T-SRecalls & reported problems
Arthrex, Inc. · Augmented MGS Reamer, Locking, S · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867499034), received between Nov 4, 2025 and Nov 17, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9675T-S REAMER SEIZED UP DURING A CASE. WHILE ATTACHED TO THE AUGMENT REAMER SHAFT, AND UPON REAMING THE GLENOID, THE DRILL SEIZED AND FAILED TO ROTATE ANY FURTHER. THERE WERE NO IMPLICATIONS FOR PATIENT SAFETY, AND WE WERE ABLE TO COMPLETE THE CASE BY OPENING ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569916 ↗MalfunctionNov 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/30/2025, AN ARTHREX EMPLOYEE REPORTED VIA (B)(4) THAT (QTY. 2) AR-9675T-S AUGMENTED SMALL LOCKING REAMERS FROZE UP WITHIN THE ORIENTATION SLEEVE. THEY WERE DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569040 ↗MalfunctionNov 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/30/2025, AN ARTHREX EMPLOYEE REPORTED VIA (B)(4) THAT (QTY. 2) AR-9675T-S AUGMENTED SMALL LOCKING REAMERS FROZE UP WITHIN THE ORIENTATION SLEEVE. THEY WERE DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569037 ↗MalfunctionNov 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS REPORTED BY THE SALES REP ON 07-JAN-2026 THAT THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH AUGMENTED BASEPLATE. A GLENOID WAS BEING REAMED AND THE PATIENT'S BONE QUALITY WAS FAIR AND FIRM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465729 ↗
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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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