Arthrex® AR-6420CEXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867039209), received between Oct 1, 2019 and May 11, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Physical Resistance/Sticking

  ON 23-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6420CEX CURVED EXCALIBER BROKE DURING A CASE, THE INNER CUTTING SHEATH WOULD STOP SPINNING WHEN SHAVING THE CAPSULE. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140082 ↗
• MalfunctionMay 11, 2026Physical Resistance/Sticking

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6420CEX CURVED EXCALIBER BROKE DURING A CASE, THE INNER CUTTING SHEATH WOULD STOP SPINNING WHEN SHAVING THE CAPSULE. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140059 ↗
• MalfunctionMay 11, 2026Physical Resistance/Sticking

  ON 23-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6420CEX CURVED EXCALIBER BROKE DURING A CASE, THE INNER CUTTING SHEATH WOULD STOP SPINNING WHEN SHAVING THE CAPSULE. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140049 ↗
• MalfunctionMay 11, 2026Physical Resistance/Sticking

  ON 23-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6420CEX CURVED EXCALIBER BROKE DURING A CASE, THE INNER CUTTING SHEATH WOULD STOP SPINNING WHEN SHAVING THE CAPSULE. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25139961 ↗
• InjuryJun 13, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE AR-6420CEX (LOT: 15104511) BROKE AND BECAME VERY HOT. THE DEVICE BURNED THE PATIENT'S SHOULDER AND SURGEON'S FINGER. 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: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 19527580 ↗
• InjuryOct 1, 2019Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY THE ARTHREX DEVICE AR-6420CEX WAS USED. DURING THE SHAVER PROCESS IT WAS NOTICED THAT METAL ABRASIONS OF THE DEVICE CAME INSIDE THE JOINT. THE SURGEON TRIED TO SUCTION THE ABRASIONS BUT HE CAN'T CONFIRM THAT THERE ARE NO MICRO PARTS OF THE METAL REMAINING INSIDE THE PATIENT. NO FURTHER INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9141765 ↗