Arthrex® AR-6420CDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867039193), received between Jan 23, 2023 and Jan 13, 2026 — classified as 4 malfunctions.

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

• MalfunctionJan 13, 2026Material Fragmentation

  ON 19-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6420CDS CURVED DISSECTOR LEFT METAL SHAVINGS BEHIND. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED BY THE REP ON 23-DEC-25 THAT THIS WAS DISCOVERED DURING A HIP SCOPE. THE SHAVINGS WERE DISCOVERED DURING THE DEBRIDEMENT OF LABRUM. ALL FRAGMENTS WERE RETRIEVED. BOTH SUCTION AND IRRIGATION WERE USED, AND NO ALARMS WERE PRESENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053050 ↗
• MalfunctionJan 13, 2026Material Fragmentation

  ON 19-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-6420CDS CURVED DISSECTORS LEFT METAL SHAVINGS BEHIND. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED BY THE REP ON 23-DEC-25, THAT THIS WAS DISCOVERED DURING A HIP SCOPE. THE SHAVINGS WERE DISCOVERED DURING THE DEBRIDEMENT OF LABRUM. ALL FRAGMENTS WERE RETRIEVED. BOTH SUCTION AND IRRIGATION WERE USED, AND NO ALARMS WERE PRESENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052835 ↗
• MalfunctionApr 24, 2025Break; Break

  ON 04/08/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-6420CDS DISSECTOR SHAVER BLADE BROKE. THIS WAS DISCOVERED DURING THE CASE. THERE WERE NO FRAGMENTS AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901835 ↗
• MalfunctionJan 23, 2023Material Fragmentation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY DEBRIS WAS PRODUCED WITH THE DEVICE. 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. UPDATE AVOE (B)(6) 2023 IT WAS CONFIRMED THAT ALL FRAGMENTS COULD BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223081 ↗