Arthrex® AR-9510RG-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061798), received between Jan 31, 2024 and Jun 8, 2024 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED, DURING A RTSA USING OUR MODULAR GLENOID SYSTEM, DURING THE HUMERAL CUP REAMING, THE SURGEON COULD NOT GET THE HUMERAL CUP REAMER GUIDE TO STAY WITHIN THE BROACH. THE SURGEON COULD NOT GET A TACTILE FEEL THAT THE GUIDE WOULD STAY IN PLACE AND THIS CAUSED HIM TO REAM HIGHER THAN HE WANTED TO. THE SURGEON USED OUR BACK-UP SET TO TRY DIFFERENT HUMERAL CUP REAMERS, BUT THOSE TOO DID NOT SIT WITHIN THE BROACH THE WAY THEY WERE DESIGNED TO DO SO. THE BLACK RING AROUND THE HUMERAL CUP REAMERS THAT ALLOWS THE GUIDE TO CLICK WITHIN THE BROACH HAS BEEN WORN AND DEFECTIVE. THE CASE WAS COMPLETED BY THE SURGEON REAMING OVER THE PIN AND SECURING THE CUP WITHIN THE HUMERUS AND HE WAS SUCCESSFUL WITH THE RTSA CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494469 ↗
• MalfunctionJan 31, 2024Break; Break

  ON 12/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE HAD THE TIP OF THE HANDLE BREAK OFF IN THE AR-9510RG-C ARTHREX UNIVERS REVERS REAMER GUIDE. THE CASE WAS COMPLETED BY SWAPPING FOR ANOTHER DEVICE WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 1/15/2023: THE CASE WAS COMPLETED USING A 2ND HANDLE INSIDE THE SET. THERE WAS A 10 MINUTE DELAY IN THE CASE TO GET THE DRILL GUIDE REMOVED. ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612411 ↗