Arthrex® AR-5400-14Recalls & reported problems
Arthrex, Inc. · SIZE 14 LEG, GLENOID TARGETER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867315419), received between Jan 26, 2024 and Mar 4, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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/Sticking4
- Use of Device Problem2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Physical Resistance/Sticking
ON 11-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-14 GLENOID TARGETER, SIZE 14 LEG WAS WORN OUT AND WOULD NO LONGER GO ON THE MAIN BODY OF THE VIP SLEEVE. THIS WAS DISCOVERED AFTER USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506531 ↗MalfunctionJan 19, 2026Physical Resistance/Sticking
ON 02-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-14 VIP GLENOID TARGETER WOULD NOT SLIDE DOWN THE GUIDE HANDLE DURING A CASE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108436 ↗MalfunctionMar 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/27/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-14 VIP¿ GLENOID TARGETER WILL NO LONGER SLIDE INTO THE SHAFT. THE LEG SEEMS TO NOT MOVE FREELY UP AND DOWN THE SHAFT AS IT SHOULD. THIS ISSUE WAS DISCOVERED DURING THE CASE BUT THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619934 ↗MalfunctionNov 20, 2024Naturally Worn; Naturally Worn
ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-14 SIZE 14 LEG, GLENOID TARGETER IS WORN OUT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733470 ↗MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem
ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-14 VIP¿ GLENOID TARGETER HAS AN ISSUE WITH THE THREADING. THIS OCCURRED DURING A CASE WHERE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 19345196 ↗MalfunctionJan 26, 2024Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT A SIZE 14 GLENOID TARGETER LEG, AR-5400-14, IS NOT SLIDING DOWN THE SHAFT OF THE VIP TARGETER. NOTICED DURING CASE, NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18586183 ↗
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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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