Arthrex® AR-8400SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867043633), received between Aug 10, 2021 and May 14, 2024 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY AFTER OPENING THE PACKAGE, THE SURGEON NOTICED THAT THE BLADE WAS CROOKED AND NOT SUITABLE FOR SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310515 ↗
• MalfunctionFeb 16, 2023Break; Connection Problem

  IT WAS REPORTED THAT PRIOR TO A SURGERY THE CUSTOMER HAD DIFFICULTIES TO ATTACH THE SHAVER BLADE ONTO THE HANDPIECE. THE CUSTOMER THE USED BETADINE WHICH ALLOWED THE ATTACHMENT TO SLIDE ENOUGH TO BE PUT IT ON THE HANDPIECE. THE SURGERY WAS THEN FINISHED SUCCESSFULLY HOWEVER AT THE END OF THE SURGERY WHEN THE SURGEON REMOVED FROM IT THE PORTAL (INCISION SITE SHOULDER) THE BLADE BROKE OFF. THE CUSTOMER FURTHER REPORTED THAT THE POINT OF BREAKAGE WAS FROM THE INSIDE TO THE OUTSIDE AND APPEARED TO BE AS IT HAD BEEN TWISTED OFF. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16385424 ↗
• InjuryAug 10, 2021Break

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY SURGERY THE SHAVER BLADE DID BREAK OFF. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12300872 ↗