Arthrex® AR-5400-13Recalls & reported problems
Arthrex, Inc. · SIZE 13 LEG, GLENOID TARGETER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867315402), received between Jun 3, 2024 and Jan 21, 2026 — classified as 5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking2
- Positioning Failure2
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2026Positioning Failure
ON 06-JAN-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-13 VIP GLENOID TARGETER LEG WAS NO LONGER LOCKING CORRECTLY INTO THE GLENOID TARGETER SHAFT DUE TO BECOMING WARPED FROM WEAR AND TEAR DURING A CASE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24129962 ↗MalfunctionOct 29, 2025Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking
ON 10/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-13 GLENOID TARGETER WOULD NOT SLIDE DOWN THE VIP TARGETING GUIDE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413090 ↗MalfunctionMay 15, 2025Positioning Failure; Positioning Failure
ON 04/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-5400-13 SIZE 13 LEG GLENOID TARGETER WAS UNABLE TO BE INSERTED INTO THE SHAFT GUIDES. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027813 ↗MalfunctionJun 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 05/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-13 SIZE 13 LEG TARGETER DOES NOT SLIDE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547978 ↗MalfunctionJun 3, 2024Use of Device Problem; Use of Device Problem
ON 05/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-13 GLENOID TARGETER IS NOT SLIDING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19447109 ↗
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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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