Arthrex® AR-5410-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867392250), received between Oct 31, 2023 and Nov 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-02 GLENOID TARGETER HANDLE AND AN AR-5410-01 VIP GLENOID REAMER PILOT WERE WORN. THE CASE WAS COMPLETED BY SWAPPING OUT THE DEVICES. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110764 ↗
• MalfunctionOct 31, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06049844 THAT AN AR-5410-01 VIP GLENOID REAMER, PILOT SHARP EDGE ON THE BUTT OF THE CALIBRATED PORTION CAUSED DAMAGE TO THE AR-9216-4 DRILL GLOVE PROTECTOR BY LEAVING BITS OF PLASTIC SHAVINGS IN THE PATIENT'S SHOULDER WOUND. THE CASE WAS COMPLETED SUCCESSFULLY BY RETRIEVING THE PIECES LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023. PRODUCT CHECKLIST WAS UPDATED AND ADDITIONAL INFORMATION RECEIVED ON 10/24/2023: THERE WAS A UNSPECIFIED AMOUNT OF DELAY WHEN REMOVING ALL THE FRAGMENTS FROM THE PATIENT AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ADVERSE EFFECTS FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037781 ↗