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Arthrex® AR-18716P-10Recalls & reported problems

Arthrex, Inc. · Y-Plate, 1.6mm, 6 Hole · Class 2 · Implant

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 00888867313422), received between Jun 14, 2021 and Jun 14, 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
  • Difficult to Remove1
  • Material Twisted/Bent1

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.

  • MalfunctionJun 14, 2021Break; Difficult to Remove; Material Twisted/Bent

    IT WAS REPORTED DURING A PROCEDURE THE AR-18716P-10 PLATE WAS DAMAGED DURING THE ATTEMPTED CUT AND THE TIP OF THE AR-18700-09 DRIVER BROKE OFF INTO THE SCREW HEAD. ADDITIONAL INFORMATION PROVIDED 6/8/21: THE BROKEN TIP OF AR-18700-09 WAS UNABLE TO BE REMOVED FROM THE SCREW HEAD. THE DRIVER TIP BROKE COMPLETELY FLUSH WITHIN THE SCREW HEAD AND THE SURGEON WAS UNABLE TO REMOVE IT. THE CASE WAS COMPLETED BY REMOVING THE ENTIRE SCREW FROM THE PATIENT USING A NEEDLE NOSE PLIERS, AND USING A LESS OPTIMAL PLATE BECAUSE THE MOST OPTIMAL PLATE WE NEEDED WAS BENT DURING AN ATTEMPTED CUT. BOTH DEVICES WERE DISCARDED.

    Patient problems: Insufficient Information

    MAUDE report 11991255 ↗

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Sources and updates

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