MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE & UNIVERS II RESECT GD L,RT; MANUAL INSTR, GENERAL SURGICAL

Model Number	ECLIPSE & UNIVERS II RESECT GD L,RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2021
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 device was returned with a broken pin stuck in its cannulation.The pin od could not be measured accurately due to the damage but appears to meet the drawing specifications in effect prior to (b)(4).The pin revision is also unknown, however it is likely related to a known issue related to the upper tolerance range of the pin od addressed in (b)(4).(b)(4) was initiated to address this issue.
Event or Problem Description
It was reported that the pin from the ar-9207s set broke off in the guide.

• Brand Name: ECLIPSE & UNIVERS II RESECT GD L,RT
• 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: 19286994
• Report Number: 1220246-2024-03096
• Device Sequence Number: 7734684
• Product Code: MDM
• UDI-Device Identifier: 00888867060326
• UDI-Public: 00888867060326
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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 Model Number: ECLIPSE & UNIVERS II RESECT GD L,RT
• Device Catalogue Number: AR-9401-13
• Device Lot Number: 250180706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown