Arthrex® AR-6420CTDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867273894), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.

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

• InjuryMar 18, 2024Break; Break

  ACCORDING TO THE PATIENT¿S LEGAL REPRESENTATIVE, THE TIP OF A TORPEDO SHAVER BROKE OFF DURING A LEFT HIP LABRUM REPAIR SURGERY ON (B)(6) 2022. IT IS ALLEGED THAT THE PROVIDERS WERE UNAWARE OF THE BROKEN FRAGMENT, WHICH WAS LEFT UNRETRIEVABLE IN THE JOINT SPACE. THEREAFTER, THE PATIENT WAS EXPERIENCING PAIN AND LOCKING OF HIS HIP. ACCORDINGLY, AN MRI WAS ATTEMPTED ON (B)(6) 2023, BUT ABORTED DUE TO MACHINE MALFUNCTION (APPARENTLY DUE TO THE METAL FRAGMENT WITHIN THE HIP). A CT SCAN WAS PERFORMED INSTEAD, AND THE RETAINED METAL FRAGMENT IN THE HIP WAS DISCOVERED. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2023, FOR RETAINED FRAGMENT REMOVAL AND A TOTAL HIP ARTHROPLASTY. THE SECOND SURGERY WAS PERFORMED BY A DIFFERENT SURGEON AT ANOTHER FACILITY, AND THE IMPLANTS WERE ANOTHER MANUFACTURER¿S DEVICES.

  Patient problems: Pain

  MAUDE report 18921595 ↗