MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 51MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ECLIPSE TRUNION 51MM, SLOTTED, TPS CAP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
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
On (b)(6) 2023, it was reported by a sales representative via email that while using an ar-9301-03 arthrex eclipse cage screw large, an ar-9400-sbk eclips speedscap implant system and an ar-9301-51cpc eclipse trunion, during the final steps, the surgeon drilled the pilot hole into the screw and fixation was compromised.Surgeon moved to an apex system instead.While using the apex, fixation was also compromised when trailing the head, so surgeon used a larger size instead.Additional information requested.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging during use.

• Brand Name: ECLIPSE TRUNION 51MM, SLOTTED, TPS CAP
• Common Device Name: 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: 16341476
• Report Number: 1220246-2023-06255
• Device Sequence Number: 6873276
• Product Code: QHQ
• UDI-Device Identifier: 00888867276185
• UDI-Public: 00888867276185
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• 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,Followup
• Report Date (Section B): 09/04/2024

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: 01/31/2025
• Device Model Number: ECLIPSE TRUNION 51MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-51CPC
• Device Lot Number: 19.04146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown