Arthrex® AR-9202-25HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867058446), received between Nov 20, 2024 and Nov 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionNov 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12TH NOVEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9202-25H ARTHREX UNIVERS II WAS STUCK/LODGED ON THE T HANDLE. THIS WAS DETECTED DURING USE IN AN RTSR PROCEDURE ON (B)(6) 2024. WHEN SURGEON WAS PERFORMING RTSR, ARTHROPLASTY CASE, THE UNIVERSE II REAMER, 5 MM HUDSON CONNECT WAS STUCK/LODGED ON THE T HANDLE. IT WAS NOT ABLE TO DISCONNECT DURING SURGERY AND ONLY 1 T HANDLE COULD BE USED FOR THE REMAINDER OF THE SURGERY, WHICH CAUSED INCONVENIENCE FOR THE SURGEON. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM BY USING 1 T HANDLE FOR THE REMAINDER OF THE REAMERS. AFTER THE SURGERY, IT WAS IDENTIFIED THAT THE ISSUE WAS WITH THE REAMER AND NOT WITH THE T HANDLE. SCRUB NURSE AND SURGEON TRIED TO DISCONNECT THE REAMER FROM THE T HANDLE BUT WERE UNSUCCESSFUL DURING SURGERY. WHEN SURGERY WAS COMPLETED, IT WAS DISCONNECTED BY THE CSU STAFF.

  Patient problems: Insufficient Information

  MAUDE report 20733660 ↗