MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, CPR MINI SCORPION DX; POLYETHYLENE SYNTHETIC SUTURE

Model Number	IMPLANT SYSTEM, CPR MINI SCORPION DX
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/23/2021, it was reported by a facility representative via e-mail that a ar-8690ds implant system is defective.The pigtailed lassos were defective.The wires were unable to be passed through the cannulation.Additional information requested.Additional information provided on 11/24/2021 : the case was completed using a second set that was opened and the suture passers were operating properly.
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 user error of the device due to excessive force used during suture passing/tightening/tensioning.

• Brand Name: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19182079
• Report Number: 1220246-2024-02393
• Device Sequence Number: 17992805
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Expiration Date: 09/30/2025
• Device Model Number: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 12002947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown