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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.
Event or Problem Description
It was reported during during a hemi shoulder arthroplasty procedure, the version rod broke off the ar-9401-13 head cut guide.The threaded portion of the version rod is now stuck inside the guide.The case was still successful and no harm was done.See attached images.Additional information received on 5/26/2021: the rep provided the part number of the version rod that broke during the procedure (ar-9202).The version rod broke while the guide was in use.The rods are threaded into the top of the guide, and are not directly in the patient but above the humerus.

• 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: 19526626
• Report Number: 1220246-2024-05653
• Device Sequence Number: 15341012
• Product Code: MDM
• UDI-Device Identifier: 00888867060326
• UDI-Public: 00888867060326
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/13/2024

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: 250090303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown