Arthrex® AR-8500DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867043794), received between Apr 12, 2021 and Dec 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A BURSA SHAVING SHOULDER SURGERY THE DEVICE BROKE OFF AT THE NECK OF THE DEVICE WHICH IS LOCATED OUTSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18394007 ↗
• MalfunctionFeb 14, 2022Break

  IT WAS REPORTED THAT DURING AN ELBOW SURGERY WHILE SMOOTHING THE CARTILAGE THE DEVICE BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE PART OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 13528044 ↗
• MalfunctionOct 12, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DEVICE BROKE INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 12615537 ↗
• MalfunctionApr 12, 2021Degraded; Material Erosion

  IT WAS REPORTED THAT TWO DEVICES FROM THE SAME LOT (11982055) PRODUCED METAL ABRASION DURING A KNEE SURGERY. ACCORDING TO THE NURSE NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE KNEE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 2021: IT WAS CONFIRMED THAT THE METAL ABRASION OCCURRED INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER BUT DIFFERENT LOT NUMBER. THE TWO AFFECTED DEVICES WERE DISCARDED BY THE FACILITY AND THE REMAINING DEVICES OF THE PACKAGE PLUS AN ADDITIONAL PACKAGE OF THE AFFECTED LOT WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 11647652 ↗