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

Model Number	ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
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 1/5/2023, it was reported by a sales representative via email that while using a swivelock from an eclipse speedscap implant system, it broke.An ar-2326bcc biocomposite swivelock was opened and while passing the suture through the eyelet, it snapped off.Another ar-2326bcc biocomposite swivelock was opened, and the same thing happened, the eyelet snapped off while passing the suture through it.This was discovered during an tsa procedure on (b)(6) 2023.Neither anchor was implanted, as this was all outside of the patient, prior to implantation.Case was completed using a 4.75 mm swivelock.Additional information received on 1/5/2023: the swivelock from the eclipse speedscap implant system, part number ar-9400-sbk, had the eyelet break off inside the patient during insertion.All fragments were retrieved.The case was completed using ar-2324bcc biocomposite swivelocks.
Additional Manufacturer Narrative
The complaint device was not returned; therefore, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos 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: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 16223347
• Report Number: 1220246-2023-06149
• Device Sequence Number: 20409831
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: 01/05/2023
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown