Arthrex® AR-5400-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867315341), received between May 22, 2024 and Mar 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 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.

• MalfunctionMar 21, 2025Defective Device; Defective Device

  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 21662875 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 02/15/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-02 TARGETING HANDLE PRONGS ARE BENT AND WILL NOT SEAT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549903 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 2/3/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-5400-02 GLENOID TARGETER HANDLE HAD AN ISSUE. THE TOP PART OF THE ITEM WAS LOOSE AND SEEMED TO BEND WHEN TRYING TO ENGAGE. THEY HAD TO OPEN UP ANOTHER PAN AND USE THE ONE FROM IT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459367 ↗
• MalfunctionMay 22, 2024Fitting Problem; Fitting Problem

  ON 08/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-02 GLENOID TARGETER HANDLE AND AN AR-5400-01 GLENOID TARGETER SHAFT HAD AN ISSUE. DURING AN UNSPECIFIED PROCEDURE, THE AR-5400-01 GLENOID TARGETER SHAFT SLOT A WOULD NOT ALLOW THE ARM TO SLIDE IN, AND THE AR-5400-02 GLENOID TARGETER HANDLE WOULD NOT ALLOW THE ARM TO SLIDE INTO THE A SLOT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 08/31/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS EVENT OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2022. THE SURGEON USED A HEMOSTAT TO GUIDE THE DEVICE INTO THE A SLOT, AND BOTH DEVICES THEN WERE USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THESE INSTRUMENTS COULD NOT BE USED ANYMORE AFTER THE COMPLETION OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370506 ↗