Arthrex® AR-8300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867043138), received between Sep 8, 2023 and Feb 14, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. 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.

• InjuryFeb 14, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE SHAVER WAS USED DURING SURGERY WHEN PATIENT GOT CARDIAC ARRHYTHMIA. SURGEON STOPPED THE SHAVER. WHEN THE SURGEON USED THE SHAVER AGAIN, THE CARDIAC ARRHYTHMIA OCCURRED AGAIN WITH THE PATIENT. AFTER SECOND USE THE SURGEON WAS FINISHED WITH USAGE OF THE SHAVER AND THEREFORE HE DIDN´T NEED TO CHANGE THE SHAVER. THE PATIENT IS WELL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE SWIT 15-DEC-2020: THE ARTHREX SHAVER AR-8330F ONLY INFLUENCED THE ECG DEVICE IN THE DISPLAY OF CONDUCTION. THE PATIENT DID NOT HAVE ANY ARRHYTHMIAS AT ANY TIME. THE SHAVER IN QUESTION WAS REPLACED DURING THE SURGERY. WITH THE REPLACEMENT DEVICE, THERE WAS NO FURTHER CHANGE ON THE ECG MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703689 ↗
• MalfunctionOct 30, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE SHAVER CONSOLE IS DEFECTIVE. IT DOES NOT WORK WHEN PLUGGING IN THE SHAVER HANDPIECE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031484 ↗
• MalfunctionSep 8, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT WITH THE ATTACHED HANDPIECE THE SCREEN SHOWES THAT IT IS NOT CONNECTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709945 ↗