Arthrex® AR-8730-46HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867304017), received between Jan 31, 2022 and Dec 27, 2023 — classified as 2 malfunctions.

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

• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SCREW BROKE WHEN THE SURGEON TRIED TO REMOVE IT FROM THE PATIENT. THE BROKEN SCREW COULD NOT BE RETRIEVED FROM THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18406050 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING A METAL REMOVAL OF TWO SCREWS AR-8730-42HS (LOT 10327710) AND AR-8730-46HS (LOT 10327712) THE HEAD OF THE SCREW AR-8730-46HS (LOT 10327712) BROKE DURING UNSCREWING WITH THE NORMAL SCREWDRIVER FOR THE DEVICE. THE DEVICE AR-8737-62 (LOT 1391931) WAS THEN USED TO GRASP THE BROKEN SCREW AND ALSO BROKE. THE BROKEN SCREW HAD TO BE CHISELED FREE TO REMOVE IT, WHICH CAUSED MUCH DAMAGE TO THE BONE. THE DURATION OF THE SURGERY WAS PROLONGED BY APPROXIMATELY 45 MINUTES DUE TO THE FAILURES. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY AND IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13396606 ↗