MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE CAGE SCREW M, 35MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 02/19/2020

Event Type  Injury  

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.

Event Description

It was reported during an eclipse total shoulder procedure, the surgeon sawed the humeral head off, put cap on the humerus and completed the glenoid without issue.When the surgeon came back to complete the humerus, the bone quality was very poor and the ar-9301-01 (lot: 18.01100) cage screw would not hold.Upon pulling out the cage screw it was noted that the screw was full of bone.The surgeon then switched to a longer cage screw (ar-9301-02 / lot: 18.01106) to get a deeper bite, but it pulled out as well.The rep stated at this point the surgeon was very upset, and decided to remove all implanted product and switch to an mgs reverse total shoulder.The rep reported no additional incisions were needed, just a different implant system was used to complete the procedure without further issue.The following products were first implanted, and then immediately explanted; ar-9301-01 / lot: 18.01100 - eclipse small cage screw, ar-9301-02 / lot: 18.01106 - eclipse medium cage screw, ar-9301-41cpc / lot: 18.01145 - eclipse trunnion size 41, ar-9121-01 / lot: 170139713 - glenoid inlay small, ar-9165-25nl / lot: 10221985 - central non-locking screw, ar-9145-36 / lot: 18.00586 - peripheral locking screw, ar-9145-24 / lot: 18.00585 - peripheral locking screw, ar-9165-25nl / lot: 10204555 - central non-locking screw (the rep stated screw was dropped on the floor and had to be wasted), ar-9120-01pc / lot: 17.01676 - revers glenoid.All removed products were discarded and will not be returning for evaluation.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• 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: 9810634
• MDR Text Key: 193019452
• Report Number: 1220246-2020-01758
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 18.01106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other