Arthrex® AR-8963-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867230651), received between Oct 7, 2024 and Apr 20, 2026 — 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 18, 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.

• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT THE DRILL BIT IS BROKEN IN THE FOOT AND ANKLE ROTATION BOX. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THIS WAS NOTICED BEFORE THE SURGERY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE 01-APR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING A SURGERY, THE DRILL BIT BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER. UPDATE 01-APR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE AR-8963-05 HAS ALREADY BEEN USED SEVERAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24928326 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A DISTAL TIBIA CLOSING WEDGE OSTEOTOMY THE DRILL BIT BROKE OFF. IT WAS FURTHER REPORTED THAT HALF OF THE DRILL REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20383771 ↗