Arthrex® AR-8719DS-2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867288164), received between Nov 1, 2018 and Aug 7, 2026 — classified as 2 injuries.

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.

• InjuryAug 7, 2026Break

  On 22nd July 2026, Arthrex became aware of a published case report titled "Incidence and Associated Factors of 2-Legged Nitinol Staple Breakage in Foot and Ankle Surgery". The AR-8719DS-2020, DynaNite¿ Nitinol Staple Implant System, 20W x 20L, was used in a calcaneocuboid joint lengthening and arthrodesis procedure on May 24, 2021.Postoperatively, breakage of the device in patient and the development of a symptomatic non-union were observed. Revision surgery involving fixation with staples and screws was performed on December 6, 2021.The patient's postoperative progress was favorable.The attending physician determined that there was no direct causal link between the staple breakage and the formation of the non-union; therefore, the case was not considered to involve harm to the patient's health resulting from product quality issues.This case was identified internally by Arthrex through the attached academic literature, and a follow-up inquiry with the physician was subsequently conducted by a sales representative.Source Citation:Ikuta Y, Nakasa T, Ishibashi S, et al. Incidence and Associated Factors of 2-Legged Nitinol Staple Breakage in Foot and Ankle Surgery. Foot & Ankle Interna

  Patient problems: Failure of Implant

  MAUDE report 50176536 ↗
• InjuryNov 1, 2018Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPIDUS PROCEDURE IN (B)(6) 2018 WHERE A DYNANITE NITI STAPLE, AR-8719DS-2020 WAS IMPLANTED INTO HER RIGHT FOOT. ABOUT FOUR MONTHS POST-OP, THE PATIENT SCHEDULED AN APPOINTMENT WITH HER SURGEON AS THE DYNAMITE STAPLE HAD BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(4) 2018: ORIGINAL DOS WAS (B)(6) 2018. THE PATIENT CAME TO THE SURGEON WITH NORMAL SYMPTOMS OF PAIN RELATED TO HALLUX VALGUS. THE REVISION WAS DONE (B)(6) 2018. THE STAPLE WAS REMOVED. TO BE NOTED, ACCORDING TO THE SURGEON, THE PATIENT EXPERIENCED A NON UNION, AND CONTRIBUTED TO THE BREAKING OF THE STAPLE DUE TO THE FACT THAT THE JOINT WAS STILL IN MOTION MONTHS AFTER SURGERY.

  Patient problems: Impaired Healing

  MAUDE report 8030465 ↗