Arthrex® AR-18716-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867313194), received between Jan 29, 2021 and Aug 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-18716-07 SCREW AND AR-18714-09 SCREW BROKE AS THE SCREW WAS BEING INSERTED, SNAPPED OFF RIGHT BELOW THE HEAD. AN AR-18716P-10 PLATE AND AR-18714P-10 PLATE WERE USED IN THE PROCEDURE, AND HAD TO BE DISCARDED AS WELL. THIS WAS DISCOVERED DURING A CASE, SCREW THREADS WERE LEFT IN PATIENT, PROCEDURE COMPLETED USING COMPETITOR PRODUCTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17509770 ↗
• InjuryJan 29, 2021Break; Material Separation

  IT WAS REPORTED THAT DURING A (B)(6) 2021 PROCEDURE THE SURGEON DRILLED FOR A 1.6 X 7 CORTICAL SCREW. UPON IMPLANTING THE SCREW THROUGH THE PLATE THE HEAD OF THE SCREW BROKE OFF. ADDITIONAL INFORMATION OBTAINED 1/19/21: PROCEDURE WAS A METACARPAL FRACTURE. THE LOT NUMBER OF THE SCREW IS UNKNOWN. ALL PIECES OF THE SCREW WERE FULLY RETRIEVED AND ACCOUNTED FOR. THE SURGEON KEPT THE REMAINING BODY OF THE SCREW IN THE PATIENT AND CONTINUED TO DRILL AND FILL THE PLATE.

  Patient problems: Insufficient Information

  MAUDE report 11251289 ↗