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	Insufficient Information (4580)
Date of Event	10/07/2025
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 10/08/2025, a sales representative reported via email that the drill bit for the ar-8717ds-0910 dynanite nitinol staple implant system did not fit through the guide and was cold-welded to it.When this occurred, the drill jerked and slipped out of the physician¿s hands.No further details were provided.This was discovered during a procedure on (b)(6) 2025.Additional information has been requested on 10/09/2025.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence of an ar-8717ds-0910, batch 3324136613, that displays that the dynanite nitinol staple implant system did not fit through the guide.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 user error of the device due to misaligned insertion.

• 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: 23316782
• Report Number: 1220246-2025-04660
• Device Sequence Number: 14909759
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: (01)00888867288058(11)240101(17)281231(10)3324136613
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/02/2026

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 9WX10L
• Device Catalogue Number: AR-8717DS-0910
• Device Lot Number: 3324136613
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown