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

Model Number	ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/4/2023, it was reported by a sales representative via email that the three fibertaks from an ar-9400-sbk eclipse speedscap implant system, pulled out of implantation site.The case was completed successfully using the swivelocks.This was discovered during a procedure on (b)(6) 2023.Additional information received on 1/5/2023: the swivelocks that were used to complete the case were not part of the kit, but instead surgeon used individual ar-2324bct-2 biocomposite swivelock.This was discovered during a shoulder hemi arthroplasty procedure.Nothing broke inside the patient and all the fibertaks that pulled out, were fully removed.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 19202772
• Report Number: 1220246-2024-02553
• Device Sequence Number: 7927394
• Product Code: MBI
• UDI-Device Identifier: 00888867356733
• UDI-Public: 00888867356733
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 15014108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 04/29/2024
• Date Device Manufactured: 10/20/2022
• 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