Arthrex® AR-5400-04Recalls & reported problems
Arthrex, Inc. · GLENOID TARGETER LOCKING NUT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867315365), received between Mar 26, 2025 and Mar 26, 2025 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 WERE 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 21696800 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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