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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
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 allegation cannot be confirmed without the device for evaluation.The device was not received for evaluation, and no photos of the failure were provided.Per the event description, the most likely cause(s) for the reported failure can be attributed to user error or improper device surgical technique.
Event or Problem Description
It was reported that the right curved red handled micro suture lasso within the ar-8690ds implant system, had some sort of blockage in the cannula toon which prevented advancement of the wire.The surgery was completed successfully.

• 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: 19525349
• Report Number: 1220246-2024-05652
• Device Sequence Number: 7549690
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 11930099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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