Arthrex® AR-8500COERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867043756), received between Feb 3, 2021 and Sep 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE LITTLE PLASTIC/ACRYLIC PIECE DETACHED FROM THE BURR AND STAYED INSIDE OF THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17839744 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component

  ON 06/29/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT ON (B)(6) 2022 DURING A ROTATOR CUFF REPAIR A AR-8500COE BURRS CLEAR PORTION ON THE TIP CAME OFF INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE CASE WAS COMPLETED USING A SMALLER BURR. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15040485 ↗
• MalfunctionFeb 3, 2021Break

  IT WAS REPORTED THAT THE HOOD OF THE AR-8500COE BROKE OFF DURING USE FOR A RCR WITH A DISTAL CLAVICLE EXCISION AND SUB-ACROMINAL DECOMPRESSION. THE PIECE WAS RETRIEVED FROM THE PATIENT; MALE, (B)(6) YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274345 ↗