MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 15WX15L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 15WX15L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 13-jan-2026, a sales representative reported via email that an ar-8719ds-1515 dynanite nitinol staple implant system experienced an issue during implantation.The staple was partially inserted a few millimeters into the bone before it fell off the inserter.When attempting to reload the staple, the tines of the inserter repeatedly popped off the staple as they attempted to spread the legs.The staple could not be reloaded and was unable to be implanted.This issue was discovered during a cotton osteotomy procedure performed on (b)(6) 2026.Additional information was received on 16-jan-2026: all fragments were retrieved.An additional ar-8719ds-1515 dynanite nitinol staple implant system of the same size was opened and implanted without issue.The case was delayed approximately 4 minutes, with no additional anesthesia reported for the patient.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 15WX15L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24248684
• Report Number: 1220246-2026-00380
• Device Sequence Number: 9593043
• Product Code: JDR
• UDI-Device Identifier: 00888867288126
• UDI-Public: (01)00888867288126(11)250407(17)300331(10)15416365
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 15WX15L
• Device Catalogue Number: AR-8719DS-1515
• Device Lot Number: 15416365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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
• Patient Sex: Unknown