Arthrex® AR-9202-28HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867058460), received between May 22, 2024 and May 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Connection Problem; Connection Problem

  ON 4/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9202-28H UNIVERS II REAMER HAD AN ISSUE. THIS CANAL REAMER "DEVICE" WAS ATTACHED TO A REAMER "T-HANDLE" IN A NORMAL MANNER AND WOULD NOT LOCK ONTO THE T HANDLE. A SECOND T HANDLE WAS USED AND IT WOULD NOT LOCK ONTO THE DEVICE AS WELL. THE NEXT SIZE LARGER CALAR REAMER WAS USED TO COMPLETE THE SURGICAL PROCEDURE IN A STANDARD FASHION. NO ADDED TIME OR ADVERSE EVENT OCCURRED. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 4/7/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A REVERSE TSA PROCEDURE ON (B)(6) 2023. NO PIECE OF THE INSTRUMENT BROKE WHILE IT WAS NOT LOCKING. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373898 ↗