Arthrex® AR-1594D-24Recalls & reported problems
Arthrex, Inc. · 2.4mm Cannulated Drill and Passing Wire · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867365896), received between May 8, 2025 and Sep 15, 2026 — classified as 4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Material Split, Cut or Torn
It was reported that during a meniscal root refixation surgery the eyelet wire tore during passing. Shuttling of the implant was no longer possible. All fragments were retrieved from the patient. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with a new device with the same part number. It was not necessary to switch the surgical technique or do a second surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775580 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715723 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715477 ↗MalfunctionMay 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 30TH APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1594D-24,2.4 MM CANNULATED DRILL AND SUTURELASSO¿ SD WIRE LOOP, THE SD WIRE BROKE WHEN SHUTTLING SUTURES. THIS WAS DETECTED DURING USE IN A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A 2ND AR-1594D-24 WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21987171 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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