MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2025
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 10/29/2025, a facility representative reported via (b)(4) that an ar-5400-400ns 2.8 mm dynamite vip glenoid nitinol pin broke off inside a patient during an rsa procedure.The procedure was successfully completed, but the broken piece was not recovered.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic of a fractured ar-5400-400ns, dynanite vip glenoid pin, batch 15442872.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as off-axis loading, improper bone preparation and prying and leveraging the device during insertion.

• Brand Name: DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23541863
• Report Number: 1220246-2025-05059
• Device Sequence Number: 9683671
• Product Code: LXH
• UDI-Device Identifier: 00888867321403
• UDI-Public: (01)00888867321403(11)250528(17)300430(10)15442872
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 VIP GLENOID PIN, NITINOL, 2.8MM
• Device Catalogue Number: AR-5400-400NS
• Device Lot Number: 15442872
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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