Arthrex® AR-2665-14HRecalls & reported problems
Arthrex, Inc. · FRAGMENT SCREW, 2.5MMX1411, HEXALOBE, · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867027664), received between Dec 16, 2019 and Dec 16, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A LEFT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2019. DUE TO PATIENT ISSUES WITH PAINFUL HARDWARE. THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2019 AT A DIFFERENT FACILITY THAN THE ORIGINAL SURGERY CENTER. ALL ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED DURING THE REVISION. NO PRODUCTS WERE IMPLANTED DURING THE REVISION PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION. THE PRODUCTS WERE KEPT BY THE PATIENT. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE EXPLANTED: AR-2655CL, CLAVICLE FRACTURE PLATE, CENTRAL THIRD -LEFT, (LOT 5261832), AR-2665-14H, FRAGMENT SCREW, (LOT 135138), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10240456), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10248912).
Patient problems: Pain
MAUDE report 9473110 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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