Arthrex® AR-8941Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867051706), received between Jul 14, 2017 and Jun 12, 2024 — classified as 3 injuries.

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 16, 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.

• InjuryJun 12, 2024Break; Break

  IT WAS REPORTED VIA A MEDWATCH REPORT THAT THE PATIENT HAD A MIDFOOT FUSION BY A DIFFERENT SURGEON BETWEEN 8-12 MONTHS AGO. THE FUSION SITE DID NOT FUSE DUE TO BROKEN HARDWARE (AR-8941), CAUSING TOO MUCH MOTION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19525334 ↗
• InjuryFeb 7, 2019Break

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF IN THE SCREW DURING REMOVAL OF A LAPIDUS PLATE. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: THE PATIENT¿S ORIGINAL IMPLANT CASE WAS A LAPIDUS PROCEDURE. THE EXPLANT PROCEDURE, WHICH WAS A REMOVAL OF A LAPIDUS PLATE AND SCREWS, TOOK PLACE ON (B)(6) 2019. DEVICES WERE BEING EXPLANTED DUE TO PATIENT PAIN. DATE OF ORIGINAL LAPIDUS SURGERY HAS NOT BEEN PROVIDED AT THIS TIME. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE (B)(6) 2019 PROCEDURE: AR-8941 LAPIDUS PLATE (QTY 1); AR-8935L-14 LOCKING SCREW, (QTY 1); AR-8935L-16 LOCKING SCREW (QTY 2); AND AR-8935-16 CORTICAL SCREW (QTY1). AFTER THE DRIVER TIP BROKE THE SURGEON CHOSE TO NOT EXPLANT THE 4.0 HEADLESS SCREW AND IT REMAINS IN THE PATIENT¿S BODY. NO FRAGMENTS OF THE BROKEN DRIVER WERE LEFT IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 8317033 ↗
• InjuryJul 14, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPIDUS BUNIONECTOMY ON (B)(6) 2015 (B)(6) MEDICAL CENTER IN WHICH A PLATE AND 5 SCREWS WERE IMPLANTED IN HER LEFT FOOT. THE PATIENT BEGAN TO EXPERIENCE FOOT PAIN BEGINNING IN THE INCISION AREA AND RADIATING OUTWARD IN (B)(6) 2017. THE PATIENT IS SCHEDULED TO HAVE THE PLATE AND 5 SCREWS EXPLANTED ON (B)(6) 2017 AS THE BONE HAS FUSED . FOLLOW INVESTIGATION: SURGEON PERFORMED A SECOND SURGERY ON (B)(6) 2017 WHERE HE EXPLANTED THE FOLLOWING DEVICES WHICH HAD BEEN IMPLANTED DURING THE (B)(6) 2015 PROCEDURE: AR-8952TT-03 QTY 1, AR-8933L-14 QTY 2, AR-8933L-12 QTY 2, AR-8933L-24 QTY 1. THE PATIENT ALSO HAD AN AR-8730-34H FULLY THREADED MINI COMPRESSION SCREW FROM THE ORIGINAL PROCEDURE THAT THE SURGEON CHOSE TO LEAVE IN THE PATIENT. DURING THE (B)(6) 2017 SURGERY, THE SURGEON WAS USING A HEXALOBE DRIVER TO REMOVE THE SCREWS AND THE TIP OF THE DRIVER BROKE OFF. THE TIP WAS RETRIEVED WITH FORCEPS AND THE CASE WAS COMPLETED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 6714787 ↗