Arthrex® AR-8970-40C-RURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867265776), received between Aug 17, 2021 and Jan 23, 2023 — classified as 2 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 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 23, 2023Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE SURGEON WAS DRILLING THE TIBIA FOR A ANKLE FUSION. HE HIT A METAL SCREW ALREADY IMPLANTED AND THE DRILL BIT SNAPPED AT THE TIP. A DIFFERENT DRILL WAS USED TO COMPLETE THE CASE. A SMALL PART OF THE DRILL STAYED IN THE PATIENT AND THE SURGEON AND HOSPITAL WERE HAPPY WITH THE OUTCOME. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16223441 ↗
• MalfunctionAug 17, 2021Break

  IT WAS REPORTED THAT DURING A TRIPLE ARTHRODESE SURGERY THE DRILL BROKE OFF AT THE AO ATTACHMENT. THE SURGEON WAS ABLE TO RETRIEVE THE PAR TOUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12332924 ↗