Arthrex® AR-8816GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867259904), received between Mar 15, 2018 and Jan 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2020Device Slipped; Unstable

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC TFCC REPAIR THE ARTHREX DEVICES AR-8816G-02 AN AR-8816G WERE USED. THE SLEEVE DOES NOT LOCK INTO THE TARGET DEVICE. IT'S SLIPPING AND IT'S UNSTABLE. THE PATIENT WAS ALREADY UNDER ANESTHESIA. THE SURGEON HAD TO CANCEL THE SURGERY AS HE HAD NO BACKUP EQUIPMENT. THE SECOND SURGERY TOOK PLACE ON THE 17TH OF DECEMBER. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568992 ↗
• InjuryMar 15, 2018Misassembled

  IT WAS REPORTED THAT THE DRILL SLEEVE IS NOT WELL FIXED INTO THE DEVICE. IT DOES NOT SPIN DURING DRILLING. BECAUSE OF THAT INCIDENT THE SURGEON HAD TO SWITCH THE SURGICAL TECHNIQUE FROM AN "TRANS-OSSEOUS DISCUS RE-FIXATION" TO AN " TRANS-SCAPULAR DISCUS RE-FIXATION". THERE WAS NO HARM FOR PATIENT, USER OR THIRD PARTY.

  Patient problems: No Code Available

  MAUDE report 7341122 ↗