MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported during a total shoulder arthroplasty, when the surgeon was going to use the eclipse, it was not sitting well and the surgeon diverted to an univers head and apex stem.No patient harm.

• Brand Name: ECLIPSE TRUNION 45MM, 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: 12306237
• Report Number: 1220246-2021-03509
• Device Sequence Number: 3164641
• Product Code: QHQ
• UDI-Device Identifier: 00888867276154
• UDI-Public: 00888867276154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183914
• 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): 08/11/2021

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: 04/30/2025
• Device Model Number: ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-45CPC
• Device Lot Number: 19.04117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/11/2021
• 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