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	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/02/2025, a sales representative reported via email that an ar-8690ds cpr mini scorpion dx implant system had an issue with the mini scorpion needle breaking while passing the suture.All broken pieces were retrieved without issues.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was provided on 10/06/2025: on (b)(6) 20225, during a plantar plate repair procedure, the needle and shaft broke inside the patient while making the second pass for the suture.The broken components were immediately visualized and successfully removed.This incident took place prior to the insertion of any implant.The bone quality was assessed as good.The procedure was completed using the pigtail lassos included in the kit.There was no case delay, no additional anesthesia administered, and no adverse effects reported during or following the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows that the distal end of the needle was broken off.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0392-sub-eo - warning - to help avoid needle breakage and potential patient injury: - do not re-sterilize or reuse the scorpion¿ suture passer needle.- avoid striking bone or using excessive force to pass the needle through fibrous/calcific tissue.If excessive force is encountered, replace the needle, reposition the device and pass in a different area.Ensure a secure grasp of tissue to prevent the needle from buckling under the tissue.Avoid ¿dry¿ repetitive actuations outside the surgical site.Abrasion of the needle surface can occur that may inhibit proper function.The most likely cause of the reported failure can be attributed to user error due to excessive force being applied during firing of the needle, resulting in the needle breaking.

• 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: 23335445
• Report Number: 1220246-2025-04687
• Device Sequence Number: 13404860
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: (01)00888867044692(11)250527(17)300430(10)15442184
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 15442184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown