Arthrex® AR-3610FRecalls & reported problems
Arthrex, Inc. · Straight Spear, FM, 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 00888867354272), received between May 21, 2024 and Jun 17, 2025 — 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
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 05/06/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3610F STRAIGHT FIBERTAK® SPEAR DRILL BIT GOT COMPLETELY STUCK INSIDE THE GUIDE AND WAS UNUSABLE. THIS OCCURRED DURING USE.
Patient problems: Insufficient Information
MAUDE report 22237160 ↗MalfunctionMay 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE DRILL BECAME STUCK IN THE DRILL GUIDE AND BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. AS THE HOLE WAS ALREADY DRILLED SUCCESSFULLY NO ADDITIONAL DEVICE WAS NEEDED TO FINISH THE SURGERY SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360909 ↗
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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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