Arthrex® AR-01-01-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867458352), received between Dec 3, 2025 and Jan 5, 2026 — classified as 2 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Failure to Auto Stop

  ON 16-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-01-01-001 DUAL TRIGGER ROTARY DRILL CONTINUED TO RUN EVEN THOUGH THE TRIGGER WAS NO LONGER ENGAGED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957762 ↗
• MalfunctionDec 3, 2025Break; Break

  ON 11/14/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-01-01-001 DUAL TRIGGER ROTARY DRILL BROKE DURING THE TRIAL. WHEN THEY PRESSED THE POWER TRIGGER, IT CONTINUED TO ROTATE DURING THE CASE. THEY WERE ABLE TO PULL ANOTHER SET OUT TO FINISH WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706107 ↗