MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 13WX10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 13WX10L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
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 03/17/2025, it was reported by an arthrex subsidiary employee via email that (qty.2) of an ar-8718ds-1310 dynanite nitinol staple implant system had an issue with the parallel drill guide in the kit when attempting to drill through the drill guide to create a bone hole.The drill got stuck in the guide.The case was completed using another ar-8718ds-1310 dynanite nitinol staple implant system.This was discovered during a hallux valgus procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 3/21/2025: nothing broke inside the patient.The case was not delayed and additional anesthesia was not needed.The patient suffered no negative effects on or after the surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Omplaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error of the device due to misaligned insertion, and/or improper surgical technique.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 13WX10L
• 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: 21774848
• Report Number: 1220246-2025-01242
• Device Sequence Number: 15503852
• Product Code: JDR
• UDI-Device Identifier: 00888867288096
• UDI-Public: (01)00888867288096(11)240501(17)290430(10)4106140419
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K243742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 13WX10L
• Device Catalogue Number: AR-8718DS-1310
• Device Lot Number: 4106140419
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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