Arthrex® AR-1610MRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867241916), received between Jul 27, 2021 and Jul 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Output Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Output Problem

  IT WAS REPORTED DURING A PROCEDURE , WHEN THE SURGEON WAS DRILLING A PIN THROUGH THE GUIDE, THE PIN DID NOT HIT THE GUIDE TO STOP THE PIN FROM ADVANCING INTO ANY STRUCTURES BEHIND THE GUIDE. THE GUIDE WAS ASSEMBLED CORRECTLY AND THERE WAS THE APPROPRIATE SIZED SHEATH IN THE GUIDE. SURGEON ADVANCED THE PIN IN A SLOW PRECISE MANNER. SURGEON ABANDONED PROCEDURE OVER SAFETY CONCERNS. ADDITIONAL INFORMATION: ON 7/8/2021: PER THE SALES REP, PIN DID NOT HIT GUIDE LIKE INTENDED. WHICH DID NOT STOP PIN FROM ADVANCING INTO STRUCTURES BEHIND GUIDE. COULDN T VISUALIZE. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 12231896 ↗