Arthrex® AR-8963-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867364349), received between Aug 5, 2024 and Aug 5, 2024 — classified as 1 malfunction.

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

• MalfunctionAug 5, 2024Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ON 07/15/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-8963-21 LAG DRILL GUIDE HAD A DRILL BIT GET STUCK INSIDE THE TISSUE PROTECTOR GUIDE, WHICH SNAPPED WHEN TRYING TO REMOVE THE DRILL BIT (PHOTO ATTACHED). NO PIECES BROKE OFF INSIDE THE PATIENT. THE SURGEON STATED THAT THE TISSUE PROTECTOR GUIDE WAS WARPED, WHICH WAS WHAT CAUSED THE DRILL BIT TO GET STUCK IN THE FIRST PLACE. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION. THIS WAS DISCOVERED DURING AN OPEN REDUCTION INTERNAL FIXATION, TARSO METATARSAL JOINT DISLOCATION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/16/2024: THERE WAS NO CASE DELAY REPORTED. THE CASE WAS COMPLETED WITHOUT AN ARTHREX PRODUCT AND COMPLETED BY FREEHAND. NO ADVERSE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 08/01/2024: THE DRILL BIT PART NUMBER IS AR-8920DC CANNULATED DRILL BIT, 3.5 MM. IT COULD NOT BE REMOVED FROM THE SLEEVE OF THE AR-8963-21 LAG DRILL GUIDE AND IS STILL INSIDE THE DRILL LAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905052 ↗