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	01/09/2025
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 (b)(6)2025, it was reported by a facility representative via (b)(4) that an ar-5400-400ns dynanite® vip¿ glenoid pin broke.This occurred during a shoulder placement procedure the pin was lodged deep in the bone and muscle.They recognized the hardware failure immediately.The removal of the pin would have caused more damage to the patient as would have likely needed to create a large bore hole in the glenoid bone or cut the glenoid in half in order to remove the pin.They decided against removal secondary to increased harm to the patient and opted to leave the pin and monitor with repeat xrays at regular intervals.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 21297094
• Report Number: 1220246-2025-00146
• Device Sequence Number: 7586049
• Product Code: LXH
• UDI-Device Identifier: 00888867321403
• UDI-Public: 00888867321403
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/09/2025

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 VIP GLENOID PIN, NITINOL, 2.8MM
• Device Catalogue Number: AR-5400-400NS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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