MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during an arthroplasty total shoulder using the eclipse, when using the central screw on the trunion, the screw locked up, which removed the central core of bone.They used the apex stem to completed the case.Additional information obtained 9/15/20: when screwing the central screw in the two components locked causing the trunion to spin and the core of bone to come off in the central screw.The surgeon then chose to abort using the planned eclipse and instead implanted an apex stem to complete the procedure.
Additional Manufacturer Narrative
Complaint not confirmed, the device was found to be undamaged.It fit the returned ar-9301-02 cage screw without difficulty and was found to meet dimensional specifications.No abnormality was found on the device that may have contributed to the event.

• Brand Name: ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10563150
• Report Number: 1220246-2020-02191
• Device Sequence Number: 14158864
• Product Code: QHQ
• UDI-Device Identifier: 00888867276147
• UDI-Public: 00888867276147
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-43CPC
• Device Lot Number: 18.01160
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other