Arthrex® AR-3610CTRecalls & reported problems
Arthrex, Inc. · Straight Spear, CT, FiberTak, Reusable · 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 00888867354258), received between Jan 5, 2026 and Feb 12, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking2
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.
MalfunctionFeb 12, 2026Physical Resistance/Sticking
ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3610CT STRAIGHT FIBERTAK REUSABLE GUIDE WELDED TO A DRILL. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE WITH NO PATIENT HARM OR CASE DELAY. THE CASE WAS COMPLETED BY OPENING UP A NON-REUSABLE DRILL GUIDE AND ANOTHER DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323728 ↗MalfunctionJan 5, 2026Physical Resistance/Sticking
ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3610CT STRAIGHT SPEAR FIBERTAK DRILL BIT WAS BOUND UP, STUCK AND WOULD NOT COME OUT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956948 ↗
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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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