Arthrex® AR-8350DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867043299), received between Aug 9, 2016 and Aug 1, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Break

  ON 7/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8350DS DISSECTOR BROKE WHEN SURGEON APPLIED PRESSURE WHILE SHAVING THE INNER LUMEN. CASE WAS COMPLETED WITH ANOTHER SHAVER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137651 ↗
• MalfunctionApr 18, 2022Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE OUTER TIP OF THE SHAVER BLADE BROKE OFF INSIDE THE PATIENT DURING NORMAL USE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136966 ↗
• MalfunctionMar 22, 2021Break

  IT WAS REPORTED THAT DURING THE USAGE OF THE SHAVER THE DEVICE QUICKLY BENT AND THE BLADE INSIDE BROKE. THE DEVICE BROKE INSIDE THE PATIENT AND NO BROKEN PARTS REMAINED INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SUTURE OF THE ROTATOR CUFF SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540375 ↗
• InjuryAug 9, 2016Break; Detachment Of Device Component

  IT WAS REPORTED THAT IN (B)(6) 2016 THE SURGEON PERFORMED AN ANKLE ARTHROSCOPY PROCEDURE WHICH WAS A WORKMAN'S COMPENSATION CASE. A FEW MONTHS AFTER SURGERY AN MRI WAS PERFORMED WHICH REVEALED A SHAVER TIP HAD BEEN LEFT IN THE PATIENT'S ANKLE FROM THE SURGERY. IT WAS REPORTED BY THE SALES REP THAT THE SURGEON BELIEVES THE TIP MAY HAVE BROKEN OFF WHEN THE DEVICE WAS PULLED OUT OF THE JOINT. ON (B)(6) 2016 A SECOND SURGERY WAS PERFORMED AND THE SURGEON REMOVED THE PIECE USING A GRASPER THROUGH A MEDIAL PORTAL. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN EXPERIENCING ANY PAIN FROM THE SHAVER PIECE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5857615 ↗