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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 06/22/2022 by a facility representative via (b)(4) that an ar-8690ds mini-scorpion nitinol wire is sticking.This was discovered during a case with no patient harm.Per facility: "dr.(b)(6) has been using arthrex for her plantar plate repairs for over 5 years.She has always used and loved the red and green lassos that come in the kit instead of using the scorpion.She has never had a problem with them until recently.I have had 3 cases with dr.(b)(6) in the last two months where the nitinol wire that is in the lassos will not come out of the tip of the lasso after pulling it back before passing through the plantar plate.First two times this happened, it only happened with the red lasso.So, we just took the nitinol wire out of the green lasso and put it in the red one and seemed to work fine.But she still wasn¿t happy.We also couldn¿t understand why one nitinol wire worked and the other one didn¿t, considering they are both the same thing.The third time was by far the worst/most embarrassing moment i have ever been in with our product.Neither lasso would work.We tried everything.Squirting saline in the lasso, getting the nitinol wire wet thinking it would slide better.Tried putting the firmer end of the nitinol wire in from the top to bottom, opened a sterile packed nitinol wire that we had on the shelf at the facility to see if that would work.It didn¿t.Nothing worked.So, we opened another kit¿.Same thing happened.I took a picture of both cpr kits we opened and kept the lassos from the cases.".
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 most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• 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: 19087285
• Report Number: 1220246-2024-01976
• Device Sequence Number: 17920338
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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
• Report Date (Section B): 04/11/2024

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: 14915644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown