Arthrex® AR-8933-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867049697), received between Dec 15, 2016 and Mar 1, 2019 — classified as 2 injuries.

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 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.

• InjuryMar 1, 2019Break; Material Fragmentation

  IT WAS REPORTED THAT TWO SCREWS BROKE DURING A LISFRANC PROCEDURE. THE FIRST SCREW AR-8740-52PTS BROKE IN HALF WHEN SPANNING BETWEEN THE FIRST METATARSAL AND THE SECOND METATARSAL. BOTH BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE SECOND SCREW THAT BROKE WAS AN AR-8933-28 WHICH WAS BEING USED IN THE PLATE. THE HEAD BROKE OFF THE SCREW; THE REMAINDER OF THE SCREW REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8381720 ↗
• InjuryDec 15, 2016Cut In Material; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A PREVIOUS 2ND TMT FUSION ON (B)(6) 2015. THE SURGEON WAS PERFORMING A 2ND TMT FUSION REVISION SURGERY ON (B)(6) 2016 DUE TO NON-UNION DURING WHICH THE FOLLOWING DEVICES WERE EXPLANTED: AR-8952TT-04, LOT 6791406 (CC100071 LINE 177084), AR-8933L-24, LOT W38572 (CC100071 LINE 177085), AR-8933L-16, LOT 1437750 (CC100071 LINE 177086), AR-8933-26, LOT 157946 (QTY 2) (CC100071 LINE 177087) AND AR-8933-28, LOT 139580 (CC100071 LINE 177088). TO COMPLETE THE REVISION PROCEDURE THE SURGEON WAS IMPLANTING AN AR-8952MS-07, 2.4MM 7 HOLE LOW PROFILE STRAIGHT PLATE (CC100071 LINE 175374) ALONG WITH AN AR-8724L-18, 2.4MM X 18MM LOW PROFILE LOCKING SCREW (CC100071 LINE 175504) WERE BEING IMPLANTED IN THIS REVISION SURGERY. A 1.7MM DRILL WAS USED TO CREATE THE PILOT HOLES FOR THE SCREWS. THE SURGEON SECURED THE PLATE WITH BB TAKS. HE THEN INSERTED A 2.4MM LOCKING SCREW, AND THE SCREW HAD CUT THROUGH THE PLATE AND DID NOT LOCK IN. THE 2.4MM PLATE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3.0 MM STRAIGHT MTP PLATE AND SCREWS. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6178155 ↗