Arthrex® AR-9350RBTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867215702), received between Jan 5, 2026 and Jan 5, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 5, 2026Complete Blockage

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-9350RBT BURR HAD A BLOCKAGE IN THE INNER TUBE. AFTER REMOVING AND CLEANING THE PARTS AND REASSEMBLING, A RUBBER TUBE CAME OUT, MAKING IT UNUSABLE. THE RUBBER TUBE WAS REMOVED, AND THE DEVICE BECAME USABLE, BUT THE CONNECTION WAS POOR, AND IT COULD NOT BE USED NORMALLY, SO IT WAS DISCONTINUED. NO RESIDUE REMAINED INSIDE THE BODY, AND NO HEALTH PROBLEMS HAVE BEEN REPORTED. A NEW UNIT OF THE SAME MODEL NUMBER WAS OPENED AND THE OPERATION CONTINUED, WHICH WAS COMPLETED WITHOUT INCIDENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961170 ↗