Arthrex® AR-8610CS-65Recalls & reported problems
Arthrex, Inc. · COUNTERSINK, FOR 6.5MM HCS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867197251), received between May 22, 2025 and May 22, 2025 — classified as 1 malfunction.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Break; Break
IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE AR-8610CS-65 COUNTERSINK BROKE DURING THE PROCEDURE. WHILE USING THE DEVICE CORRECTLY WITH THE ATTACHED HANDLE ON THE SECOND TURN THE TIP BROKE. TWO SMALL FRAGMENTS REMAINED IN THE PATIENT. THE SURGEON CONTINUED WITH THE SCREW INSERTION FOLLOWING THE INSTRUMENT BREAKAGE. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 22071167 ↗
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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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