MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW S, 30MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE CAGE SCREW S, 30MM

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, it was reported by a sales representative via email that an ar-9301-01 eclipse cage screw, an ar-9301-39cpc eclipse trunion, and an ar-9339-16 eclipse humeral head were implanted.The surgeon deemed it necessary to explant the eclipse trunion, cage screw, and humeral head, and upgrade to apex stemmed implant due to bone quality issues.This was discovered during an anatomic total shoulder replacement procedure on (b)(6) 2022.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: ECLIPSE CAGE SCREW S, 30MM
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15842716
• MDR Text Key: 304095273
• Report Number: 1220246-2022-05794
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867059924
• UDI-Public: 00888867059924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ECLIPSE CAGE SCREW S, 30MM
• Device Catalogue Number: AR-9301-01
• Device Lot Number: 20.03682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2022
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other