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Arthrex® AR-8545-26Recalls & reported problems

Arthrex, Inc. · LOW PROFILE SCREW, TI, 4.5 X 26MM · 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 00888867124486), received between Feb 23, 2017 and Feb 23, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 23, 2017Detachment Of Device Component

    IT WAS REPORTED THAT THE 4.5 MM X 26 MM TITANIUM LOW PROFILE SCREW WAS BEING USED IN AN ANKLE FUSION ANTERIOR RIGHT PROCEDURE. WHEN SCREWING IN THIS LAST SCREW, ONCE IT WAS SEATED, THE HEAD OF THE SCREW CAME OFF. THREADS REMAINED IN THE PLATE AND IN THE PATIENT. THE SCREW HEAD WAS REMOVED FROM THE PATIENT AND RETURNED FOR EVALUATION. THE QUICK CONNECT START DRIVER WAS USED TO SCREW IN THE LOW PROFILE SCREW. PATIENT, FEMALE, (B)(6)Y/O.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6352228 ↗

Other PLATE, FIXATION, BONE devices

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Sources and updates

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