MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 11X10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 11X10L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/01/2024, it was reported by an arthrex subsidiary employee via e-mail that an ar-8717ds-1110 dynanite¿ nitinol staple implant systems drill and guide locked up and became unusable.This occurred during a case where a new product was used to complete the procedure.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint 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 for the reported failure can be attributed to user-applied excessive mechanical forces.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 11X10L
• 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: 18916165
• Report Number: 1220246-2024-01516
• Device Sequence Number: 17832656
• Product Code: JDR
• UDI-Device Identifier: 00888867288065
• UDI-Public: 00888867288065
• 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): 06/06/2025

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 11X10L
• Device Catalogue Number: AR-8717DS-1110
• Device Lot Number: 3186133028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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