MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM; NON-DEGRADABLE FIXATN FASTENER

Model Number	ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/16/2024, it was reported by a sales representative via email that an ar-9400-sbk eclipse speedscap implant system did not get sufficient fixation with the eclipse trunion and cage screw.The case was completed using a long stem.This was discovered during an anatomic total shoulder procedure on (b)(6) 2024.Additional information received on 12/30/2024: the part numbers ar-9301-02 and cage screw and ar-9301-45cpc arthrex eclipse trunion were provided.Additionally, the sales representative reported that another ar-9400-sbk eclipse speedscap implant system from a different lot number and an ar-9301-01 arthrex eclipse cage screw was attempted to be used as well but still could not get sufficient fixation.The case was completed using an ar-9100-05m univers apex optifit humeral stem.The case was delayed between thirty to forty minutes; however, additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: h6.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 due to misaligned insertion and/or improper bone preparation.

• Brand Name: ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: jared engle ; 8009337001
• MDR Report Key: 21136891
• Report Number: 1220246-2025-09367
• Device Sequence Number: 20540429
• Product Code: MBI
• UDI-Device Identifier: 00888867356733
• UDI-Public: (01)00888867356733(11)241111(17)291031(10)15345465
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
• Device Catalogue Number: AR-9400-SBK
• Device Lot Number: 15345465
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown