Arthrex® AR-8741-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867362390), received between May 10, 2023 and May 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Excessive Heating” (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 16, 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.

• InjuryMay 10, 2023Excessive Heating; Excessive Heating

  ON 4/14/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT DURING AN OFFICE VISIT, THE DOCTOR MENTIONED THAT AN ARTHREX TOOL USED FOR SURGERIES GETS TOO HOT THAT IT LEAVES A BURN MARK, "LIKE A BRAND," ON HIS PATIENTS. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/19/2023: PART NUMBER AR-8741-14 GUIDEWIRE, 1.4 MM, FOR 3.5 MM AND AR-8741-16 CAPITAL FRAGMENT GUIDEWIRE 1.6MM WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/19/2023: PER THE SALES REPRESENTATIVE THAT WAS PRESENT DURING THE PROCEDURE, THIS WAS A MIS BUNION SURGERY, THE EXACT DATE IS UNKNOWN. IT IS ALSO UNKNOWN WHICH PART AR-8741-14 OR AR-8741-16 CAUSED THE PATIENT'S BURN. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Burn(s)

  MAUDE report 16906729 ↗