Arthrex® AR-9676TRecalls & reported problems
Arthrex, Inc. · Augmented Reamer Drive Shaft, Locking · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867499058), received between Oct 15, 2025 and May 26, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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/Sticking5
- Detachment of Device or Device Component1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Detachment of Device or Device Component
ON 5-MAY-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676T DRIVE SHAFT'S LOCKING PIN FELL OFF. ISSUE DISCOVERED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285454 ↗MalfunctionMar 20, 2026Physical Resistance/Sticking
ON 20-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676T AUGMENTED REAMER DRIVE SHAFT GOT BOUND UP WITH AN AR-9597-10 REAMER SLEEVE AND AN AR-9597-20 REAMER SLEEVE DURING REAMING. ADDITIONAL INFORMATION PROVIDED 3-MAR-2026: CASE WAS ABLE TO BE COMPLETED WITH OLDER INNER REAMER SHAFTS AND OLD REAMER BLADES AVAILABLE, AND THE INNER AND OUTER SHEATH HADN'T COMPLETELY COLD WELDED TOGETHER. NO OTHER PATIENT EFFECTS, A FEW MINUTE DELAY TO SWAP OUT DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647578 ↗MalfunctionMar 12, 2026Physical Resistance/Sticking
ON 19-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676T AUGMENTED DRIVE SHAFT LOCKING REAMER GOT BOUND UP AND WOULD ONLY MOVE AS ONE PIECE AS OPPOSED TO THE INNER SHEATH ROTATING FREELY WITHIN THE OUTER SHEATH OF AN AR-9597-20 ANGLED REAMER SLEEVE. THE REVERSE TOTAL SHOULDER ARTHROPLASTY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TRAY, WITH NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578724 ↗MalfunctionMar 12, 2026Physical Resistance/Sticking
ON 19-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676T AUGMENTED DRIVE SHAFT LOCKING REAMER GOT BOUND UP, AND WOULD ONLY MOVE AS ONE PIECE AS OPPOSED TO THE INNER SHEATH ROTATING FREELY WITHIN THE OUTER SHEATH OF AN AR-9597-20 ANGLED REAMER SLEEVE. THE REVERSE TOTAL SHOULDER ARTHROPLASTY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TRAY, WITH NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578716 ↗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 23569925 ↗MalfunctionNov 4, 2025Positioning Failure; Positioning Failure
ADDITIONAL INFORMATION WAS REPORTED BY THE SALES REP ON 07-JAN-26 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 23465807 ↗MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AN AR-9676T AUGMENTED REAMER DRIVE SHAFT WERE WELDED TOGETHER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303909 ↗
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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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