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Arthrex® AR-8946-08Recalls & reported problems

Arthrex, Inc. · DRIVER, CANNULATED HEX, LONG, 3.5MM · Class 1

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 00888867201781), received between May 3, 2021 and May 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionMay 3, 2021Break

    IT WAS REPORTED THAT DURING A DISTAL CALC SLIDE PROCEDURE THE SURGEON WAS USING THE AR-8946-08 DRIVER TO INSERT THE SCREW. UPON INSERTION, THE DRIVER TIP BROKE OFF IN HEAD OF THE SCREW. THE DRIVER TIP WAS FULLY REMOVED FROM THE SCREW HEAD, AND THE CASE WAS COMPLETED BY USING A BACK UP DRIVER.

    Patient problems: Insufficient Information

    MAUDE report 11761542 ↗

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Sources and updates

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