Arthrex® AR-3210-0018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867224056), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Power Up” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2019Material Discolored; Failure to Power Up; Smoking

  IT WAS REPORTED THAT THERE WAS A SMOKE DEVELOPMENT AT THE SYNERGY CONSOLE, AT THE CONNECTOR OF THE CAMERA HEAD DURING SURGERY. THE DEVICE SMELLED CHARRED AND IT WAS NOT ABLE TO TURN ON THE DEVICE. BOTH AFFECTED ITEMS WILL BE SENT IN AR-3200-0021 SN: (B)(4) AND AR-3210-0018 SN: (B)(4). THEY ALSO REPORTED THAT THE AMOUNT OF SMOKE WAS SO MUCH THAT THEY HAD TO REMOVE THE PATIENT IN THE MEANTIME FROM THE OPERATION ROOM. UPDATE 12-MARCH-2019: THEY STOPPED THE SURGERY, REMOVED THE PATIENT AND THEN BROUGHT BACK THE PATIENT LATER. UPDATE 04-APRIL-2019: THE SURGERY DIDN'T LAST ANY LONGER, THERE WAS NO HARM FOR ANYBODY. NOTHING REMAIN INSIDE THE PATIENT. NO NEW ANAESTHESIA HAD TO BE GIVEN AND THE PATIENT DID NOT HAVE TO BE TAKEN OUT OF THE ANAESTHESIA. UPDATE 24-APRIL-2019: THE PERFORMED SURGERY WAS AN SHOULDER ARTHROSCOPY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO CHANGE THE SURGICAL TECHNIQUE OR PERFORM A SECOND SURGERY. NO ADVERSE EVENT REPORTED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457834 ↗