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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2021
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 devices od were found to meet specifications of drawing c4481 rev.5, however eco-27120 was subsequently created to decrease the upper tolerance range from ±.005 in to +.001/-.005 in.
Event or Problem Description
It was reported that the 2.8mm pin from the ar-9207s, set is oversized , so the corresponding reamers (ar-9126rp and ar-9126rc) would not properly slide down the pin.Additional information 3/23/2021 it was reported that during a rtsa procedure, the 2.8mm pin from the ar-9207s, set is oversized, so the corresponding reamers (ar-9126rp and ar-9126rc) would not properly slide down the pin.The case was completed by using a 2.4 guide pin through the primary post reamer.

• 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: 19185841
• Report Number: 1220246-2024-02415
• Device Sequence Number: 12583054
• Product Code: MDM
• UDI-Device Identifier: 00888867137493
• UDI-Public: 00888867137493
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 04/25/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/25/2024
• 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