Arthrex® AR-8310Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867043145), received between Sep 7, 2023 and Oct 30, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON 09/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300DS DISSECTOR HAS WEAR MARKS AT THE SHP CONNECTION. THE PHOTO PROVIDED BY THE SALES REP SHOWED DISCOLORATION ALONG THE SHAFT OF THE DISSECTOR. PER THE SALES REP, THE OTHER DEVICES BEING USED WITH THE DISSECTOR WERE AR-8330H SHAVER HANDPIECE, AN AR-8305 SYNERGY SHAVER CONSOLE, AND AN AR-8310 SHAVER FOOTSWITCH. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MEDWATCH ON 10/10/2025: A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE WAS USED DURING A PROCEDURE ON (B)(6) 2025. AFTER THE SURGEON REMOVED THE ARTHROSCOPIC SHAVER FROM THE PATIENT AND WAS ABOUT TO PLACE IT ON THE MAYO STAND, THE SURGICAL TEAM OBSERVED THAT THE DEVICE REMAINED ACTIVE DESPITE THE SWITCH BEING TURNED OFF. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE ON 10/15/2025: PER THE REP, THE EVENT OCCURRED OUTSIDE THE PATIENT, ON THE MAYO STAND, AFTER THE AR-7300DS HAD BEEN USED AND WAS NO LONGER REQUIRED FOR THE PROCEDURE. IT IS UNKNOWN HOW LONG THE AR-7300DS WAS USED CONTINUOUSLY, AND WHETHER ANY WEAR MARKS WERE PRESENT AT THE PROXIMAL END WHERE IT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429796 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  ON 02/29/2024, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8310 FOOTSWITCH PEDAL WIRES ARE EXPOSED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923447 ↗
• MalfunctionNov 9, 2023Device-Device Incompatibility; Key or Button Unresponsive/not Working; Device-Device Incompatibility; Key or Button Unresponsive/not Working

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8310 FOOT PEDAL DOES NOT WORK, NOT PAIRING. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103848 ↗
• MalfunctionNov 9, 2023Break; Break

  ON 10/17/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06060168 THAT AN AR-8310 FOOT PEDAL IS BROKEN. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101408 ↗
• MalfunctionSep 7, 2023Electrical /Electronic Property Problem; Material Separation; Electrical /Electronic Property Problem; Material Separation

  ON 08/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8310 FOOTSWITCH CABLES ARE DAMAGED AND EXPOSED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697479 ↗