MAUDE Adverse Event Report: Arthrex, Inc. Dynanite NiTi Staple w/Instrs 20Wx20L; STAPLE, FIXATION, BONE

Model Number	Dynanite NiTi Staple w/Instrs 20Wx20L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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 international.2026;0(0).Doi:10.1177/10711007261462533.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Dynanite NiTi Staple w/Instrs 20Wx20L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50176536
• Report Number: 1220246-2026-04241
• Device Sequence Number: 9880737
• Product Code: JDR
• UDI-Device Identifier: 00888867288164
• UDI-Public: (01)00888867288164(11)200701(17)250630(10)0183104774
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: Dynanite NiTi Staple w/Instrs 20Wx20L
• Device Catalogue Number: AR-8719DS-2020
• Device Lot Number: 0183104774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown