Arthrex® AR-8741-15Recalls & reported problems
Arthrex, Inc. · Guidewire, 1.6mm, 4mm Beveled FT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867362376), received between Jan 23, 2023 and Oct 23, 2025 — classified as 3 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
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Break; Break
ON 10/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-8741-15 1.6 MM, 4MM BEVELED GUIDEWIRE BROKE DURING A CASE WITH NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366134 ↗MalfunctionMar 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 3/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A SURGEON HAS BEEN USING THE MIS BUNION SYSTEM FOR TWO YEARS AND WAS HAVING DIFFICULTY WITH TWO ARTHREX PRODUCTS, THE AR-8741-15 GUIDEWIRE AND THE AR-300-B102 BURR. WHEN USING THE AR-8741-15 GUIDEWIRE IT KEEPS GETTING STUCK WHEN SHOOTING THE K-WIRE WHEN DRILLING CAUSING THE SURGEON TO RE-FIND THE HOLE AND START OVER AGAIN. WHEN USING THE AR-300-B102 BURR IT KEEPS GETTING STUCK WHEN CUTTING WITH THE BURR AND WOULD NO LONGER CUT. THE CASES WERE COMPLETED AND NO ADVERSE EFFECTS WERE REPORTED ON ANY PATIENTS. THIS WAS DISCOVERED DURING CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18981022 ↗MalfunctionJan 23, 2023Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8741-15 GUIDEWIRE SNAPPED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16223209 ↗
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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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