Arthrex® AR-8630-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867125827), received between Oct 19, 2020 and Oct 19, 2020 — classified as 1 injury.

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.

• InjuryOct 19, 2020Break

  IT WAS REPORTED DURING A FUSION OF THE MTP USING 3.0 SMALL HEADLESS COMPRESSION SCREW, AR-8630-32, THE SCREW HEAD BROKE OFF DURING INSERTION. THE INSERTION WAS DONE BY HAND. SURGEON ATTEMPTED TO REMOVE THE SCREW AND WAS ONLY ABLE TO REMOVE PART OF IT. THE OTHER PIECE WAS LEFT IN THE PATIENT WITHOUT ANY FURTHER INCIDENT. ADDITIONAL INFORMATION PROVIDED 10/7/2020: HALF OF THE SCREW WAS LEFT UN-RETRIEVED FROM THE PATIENT. THE PATIENT'S BONE QUALITY WAS HARD AND WAS PREPPED WITH A K-WIRE, APPROPRIATE SIZE DRILL AND COUNTERSINK, WAS PUT IN BY HAND. THE CASE WAS COMPLETED BY REMOVING ABOUT HALF OF THE BROKEN SCREW, THEN FUSED THE MTP WITH 4.0 CANNULATED SCREW (NOT ARTHREX).

  Patient problems: Foreign Body In Patient

  MAUDE report 10701283 ↗