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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/22/2024, it was reported by a sales representative via e-mail that an ar-8690ds implant systems tip of the scorpion needle wouldn¿t pierce through the tissue.This occurred during a plantar plate repair on (b)(6) 2024, where they opened the kit and attempted to use the dx mini scorpion.Upon deploying the needle from the kit through the device, the tip of the scorpion needle wouldn¿t pierce through the tissue.It appeared to have broken off/bent off.The case continued using other items in the kit to repair the plantar plate.No damage or harm was caused to the patient.It did add some extra time to the case as the surgeon had a more challenging time using the pigtails from the kit, but he ended up completing the repair in an average amount of time.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is damage to the device due to misuse.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was received.

• 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: 18685517
• Report Number: 1220246-2024-00906
• Device Sequence Number: 6934150
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/02/2025

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: 15044280
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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