Arthrex® AR-5410-AMGS-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867409743), received between Jun 11, 2024 and Sep 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5410-AMGS-S VIP GLENOID REAMER WAS SECURED ON THE DRIVE SHAFT BUT IMMEDIATELY DISENGAGED AFTER SURGEON PICKED UP THE DRIVER AND THE IMPLANT FELL ON THE FLOOR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009493 ↗
• MalfunctionSep 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08/28/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT (QTY. 2) OF AN AR-5410-AMGS-S VIP GLENOID REAMER HAD AN ISSUE DURING USE. DURING THE REAMING OF AN AUGMENTED 20-DEGREE GLENOID WITH THE DEPTH OF A SMALL REAMER AR-5410-AMGS-S, THE SURGEON NOTICED THE REAMER WAS STUCK WITH A GAP WHILE STILL CONNECTED TO THE REAMER HANDLE. WHEN REMOVED, IT SEEMED STUCK IN ONE ORIENTATION RATHER THAN FREELY ROTATING. THE SURGEON REATTACHED IT AND TRIED THE TRIGGER ON THE POWERED HANDPIECE, BUT THE REAMER CREATED THAT GAP BECAUSE IT WAS STUCK IN ONE ORIENTATION. THEY ATTEMPTED TO USE A SECOND REAMER OF THE SAME PART NUMBER, BUT THE SAME EVENT OCCURRED. AFTER INSPECTION OF THE DEVICES, IT WAS NOTED THAT THE DRIVE SHAFT AND 20 AUGMENTED REAMER GUIDES WERE NOT THE ISSUE, ALTHOUGH THE TWO REAMERS HAD THE SAME PROBLEM. THEY ARE BOTH STILL STUCK IN ONE ORIENTATION, AND IT APPEARS ON THE BACKSIDE THAT CONNECTS THE REAMER HANDLE WITH METAL CUT CIRCLES SEEM TO BE MAKING CONTACT. THE CASE WAS COMPLETED BY UTILIZING A NON-DEPTH REAM AUGMENTED REAMER. A CASE DELAY OF TWO MINUTES WAS REPORTED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS EVENT WAS NOT AN UNPLANNED INCISION, AND NO SECOND SURGERY WAS NEED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215240 ↗
• MalfunctionSep 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08/28/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT (QTY. 2) OF AN AR-5410-AMGS-S VIP GLENOID REAMER HAD AN ISSUE DURING USE. DURING THE REAMING OF AN AUGMENTED 20-DEGREE GLENOID WITH THE DEPTH OF A SMALL REAMER AR-5410-AMGS-S, THE SURGEON NOTICED THE REAMER WAS STUCK WITH A GAP WHILE STILL CONNECTED TO THE REAMER HANDLE. WHEN REMOVED, IT SEEMED STUCK IN ONE ORIENTATION RATHER THAN FREELY ROTATING. THE SURGEON REATTACHED IT AND TRIED THE TRIGGER ON THE POWERED HANDPIECE, BUT THE REAMER CREATED THAT GAP BECAUSE IT WAS STUCK IN ONE ORIENTATION. THEY ATTEMPTED TO USE A SECOND REAMER OF THE SAME PART NUMBER, BUT THE SAME EVENT OCCURRED. AFTER INSPECTION OF THE DEVICES, IT WAS NOTED THAT THE DRIVE SHAFT AND 20 AUGMENTED REAMER GUIDES WERE NOT THE ISSUE, ALTHOUGH THE TWO REAMERS HAD THE SAME PROBLEM. THEY ARE BOTH STILL STUCK IN ONE ORIENTATION, AND IT APPEARS ON THE BACKSIDE THAT CONNECTS THE REAMER HANDLE WITH METAL CUT CIRCLES SEEM TO BE MAKING CONTACT. THE CASE WAS COMPLETED BY UTILIZING A NON-DEPTH REAM AUGMENTED REAMER. A CASE DELAY OF TWO MINUTES WAS REPORTED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS EVENT WAS NOT AN UNPLANNED INCISION, AND NO SECOND SURGERY WAS NEED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214685 ↗
• MalfunctionJun 11, 2024Break; Break

  ON 5/16/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5410-AMGS-S VIP GLENOID REAMER BROKE WHILE REAMING. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT WITHOUT ADVERSE EFFECTS ON THE PATIENT AND WITH NO CASE DELAY. THE CASE WAS COMPLETED SUCCESSFULLY BY REPLACING IT WITH ANOTHER. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/20/2024: THIS WAS DISCOVERED DURING A REVERSE TSA WITH AUGMENTED BASEPLATE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515059 ↗