MAUDE Adverse Event Report: ARTHREX, INC. PIN SET, UNIVERS II/ ECLIPSE; MANUAL INSTR, GENERAL SURGICAL

Model Number	PIN SET, UNIVERS II/ ECLIPSE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed, the pin was confirmed to have been made prior to eco-27120, which decreased the upper tolerance of the pin diameter to prevent interference.See eco-27120.
Event or Problem Description
It was reported that the 2.8 guide pin does not fit through the guides for the vault lock.They had to open ar-9607s for the reverse 2.8 guide pin.The reverse 2.8 fits while the eclipse 2.8 does not.

• Brand Name: PIN SET, UNIVERS II/ ECLIPSE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19212434
• Report Number: 1220246-2024-02607
• Device Sequence Number: 8105770
• Product Code: MDM
• UDI-Device Identifier: 00888867137493
• UDI-Public: 00888867137493
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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 Expiration Date: 09/30/2025
• Device Model Number: PIN SET, UNIVERS II/ ECLIPSE
• Device Catalogue Number: AR-9207S
• Device Lot Number: 11864615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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