Arthrex® AR-5400-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867315426), received between Feb 5, 2025 and Oct 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/08/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-15 VIP GLENOID TARGETER LEG WOULD NOT SLIDE INTO THE TARGETER DURING A CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412605 ↗
• MalfunctionMar 26, 2025Defective Device; Defective Device

  ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-02 VIP¿ GLENOID TARGETER HANDLE SLID EVEN THOUGH BOTH NUTS WHERE SECURED TIGHTLY. AR-5400-04 VIP¿ GLENOID TARGETER LOCKING NUT, AND A SECOND NUT FROM THE AR-4500-S SET. THIS OCCURRED DURING A REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. ADDITIONAL INFORMATION WAS PROVIDED ON 03/04/2025 WHERE THE SALES REPRESENTATIVE STATED THE ARMS THAT DIDN¿T HOLD IN PLACE WERE 10,12,15,18,25. CLARIFICATION: IT WAS REPORTED THAT THE TARGETER ARMS, AR-5400-10, AR-5400-12, AR-5400-15, AR-5400-18, AND AR-5400-25 WERE SLIDING ON THE HANDLE, DESPITE BOTH NUTS BEING SECURELY TIGHTENED.

  Patient problems: Insufficient Information

  MAUDE report 21696580 ↗
• MalfunctionFeb 5, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 01/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-5400-15 VIP¿ GLENOID TARGETER, SIZE 15 LEG WAS BENT DURING A CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 1/13/2025: THIS WAS DISCOVERED DURING A REVERSE SHOULDER PROCEDURE ON 12/30/2024. AN EXTRA GUIDE WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315276 ↗