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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2023
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 5/5/2023, a medwatch notification was received via email, reported by a facility representative that a small piece of metal from an ar-8690ds cpr mini scorpion dx and micro suturelasso implant system broke off.This was discovered during a procedure on (b)(6) 2023.No further information was reported.Additional information requested.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h3, h6: type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1, g3.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photo provided.The most likely cause for the reported failure can be attributed to user error due to misalignment insertion and/or prying/leveraging the device during insertion.

• 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: 17024761
• Report Number: 1220246-2023-06807
• Device Sequence Number: 15185466
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 14980573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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