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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 sales representative via (b)(4) that an ar-5400-400ns dynanite vip glenoid pin snapped at the 35mm mark while reaming the central post hole for an augmented mgs baseplate.The surgeon could not retrieve the pin and attempted to palpate the pin anterior to the glenoid but could not feel the pin.A mini c-arm was brought into the room to locate the broken pin.The surgeon ranged the humerus and noted the pin stayed stationed with humeral rom.Then, the surgeon moved the scapula, and the pin was moved on the x-ray in a scapular motion.The surgeon assessed that the pin must have been in the scapula, not soft tissue.The pin was left, and the surgeon completed the rest of the case as planned.This was discovered during a reverse total shoulder procedure on (b)(6) 2025.Additional information was received on 01/29/2025: the proper technique was followed per the arthrex technique guide to complete the case.There was a twenty-minute case delay in getting a mini c arm draped and positioned in the room and determining where the pin was.There was no information on additional anesthesia being administered to the patient.There was no unplanned incision due to the issue.No revision is scheduled or planned as the surgeon determined the broken fragment was safely in the scapula.No medical intervention or hospitalization was needed for the patient.There was no report of the patient experiencing a reduced quality of life due to the deviation.
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: 21375186
• Report Number: 1220246-2025-00435
• Device Sequence Number: 15561391
• Product Code: LXH
• UDI-Device Identifier: 00888867321403
• UDI-Public: 00888867321403
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 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
• Device Lot Number: 15339464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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