MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX10L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/09/2025, an arthrex subsidiary employee reported via email that the ar-8717ds-0910 dynanite nitinol staple implant system had the drill bit stuck in the drill guide.The case was completed using another ar-8717ds-0910 dynanite nitinol staple implant system.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/23/2025: this event occurred in a four-corner fusion procedure on (b)(6) 2025.No delays were reported, and no additional anesthesia was required during the surgery.There were no instances of instrument or implant breakage, and therefore, no fragments needed to be retrieved.The patient did not experience any adverse effects or significant damage during or after the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to misaligned insertion and/or prying/leveraging the devices during use.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX10L
• 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: 22385891
• Report Number: 1220246-2025-02705
• Device Sequence Number: 8761742
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: (01)00888867288058(11)240501(17)290430(10)4114140753
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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 9WX10L
• Device Catalogue Number: AR-8717DS-0910
• Device Lot Number: 4114140753
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown