Arthrex® AR-8650-08Recalls & reported problems
Arthrex, Inc. · OSTEOTOME, ANGLED UP, 5.5 MM · 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 00888867044227), received between Aug 15, 2022 and May 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Difficult to Remove1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Break; Break
ON 04/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8650-08 OSTEOTOME TIP BROKE OFF. THIS OCCURRED DURING A CASE WHEN IT WAS BARELY TAPPED THE TIP SNAPPED OFF. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19260737 ↗MalfunctionAug 15, 2022Break; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE END OF THE DEVICE SNAPPED OFF WHEN PREPARING THE ANKLE FOR FUSION. THE BROKEN OFF END OF THE DEVICE WAS STUCK IN THE PATIENTS TIBIA. THE SURGEON TRIED TO REMOVE THE FRAGMENT, BUT CAME TO THE CONCLUSION THAT HE WOULD NOT BE ABLE TO REMOVE THE FRAGMENT AND SO HE LEFT IT IN SITU. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 15223853 ↗
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- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
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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