Arthrex® AR-18714-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867303867), received between May 24, 2021 and Aug 11, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2023Break; Break

  ON 07/13/2023, 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 17514711 ↗
• MalfunctionNov 21, 2022Break; Entrapment of Device; Difficult to Insert

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-18714-08, AR-18714-07, AND A AR-18714-09 SCREW BROKE. THIS OCCURRED DURING A PHALANX FRACTURE ON (B)(6) 2022 WHEN INSERTING THE AR-18714-08 SCREW IT BROKE ABOUT 3/4 OF THE WAY, THE SURGEON THEN ATTEMPTED TO INSERT A AR-18714-09 SCREW TO SECURE THE PLATE TO THE BONE, UPON INSERTION THE SCREW BROKE. THEN A AR-18714-07 SCREW WAS USED TO SECURE THE PLATE AS IT WAS ALREADY DOWN, WHEN ATTEMPTING TO SECURE THE PLATE IT BROKE. ALL BROKEN FRAGMENTS REMAIN IN THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY AND THE SOCKETS WERE PREPPED FOR INSERTION WITH A AR-18700-06 DRILL BIT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15833687 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED THAT DURING A FIFTH METACARPAL FRACTURE, WHEN THE SURGEON WAS ADVANCING THE AR-18714-09, SCREW INTO THE PATIENT, ONCE THE SCREW WAS SETTING AT 1MM BEFORE IT WAS FULLY SEATED, THE HEAD BROKE. THE SCREW REMAINS IN THE PATIENT BUT THE HEAD THAT BROKE WAS REMOVED. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11872257 ↗