Arthrex® AR-9508-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867061545), received between Dec 8, 2022 and Dec 8, 2022 — 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.

• MalfunctionDec 8, 2022Physical Resistance/Sticking

  ON 08/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9508-36 HUMERAL CUP REAMER, AND A AR-9510RG-L REAMER GUIDE GOT STUCK. THIS OCCURRED ON (B)(6) 2022 DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY WHEN REAMING THE HUMERAL HEAD THE REVERS APEX STEM BROACH WAS IN, THE L CENTERING PEG WAS IN THE BROACH, AND WHEN IT WAS TIME TO REAM THE REAMER KEPT GETTING CAUGHT IN THE PEG WHICH WOULDN'T ALLOW IT TO REAM. THE SURGEON ENDED UP REMOVING THE CENTERING PIN AND REAMED FREEHAND. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 08/24/2022 THAT THE INSIDE OF THE REAMER LOOKS SHREDDED AND HAS NICKS FROM THE CENTERING PIN. DEBRIS WAS PRODUCED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940551 ↗