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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a shoulder case the pin was stuck inside the cut guide.When the guide was removed the pin came out.The case was completed with no further issues.
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, even though the device was not returned, one of the five sealed device that was returned was measured.The device measured.114 in and met the specifications of c4481 rev.6 it was made to.An eco has been released subsequently to decrease the upper tolerance range and decrease the opportunity of interference with the mating part.

• 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: 19173330
• Report Number: 1220246-2024-02312
• Device Sequence Number: 15286490
• Product Code: MDM
• UDI-Device Identifier: 00888867137493
• UDI-Public: 00888867137493
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown