MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CHIBA BIOPSY NEEDLE WITH ECHOGENIC TIP 22GA X 20CM; INSTRUMENT, BIOPSY

Model Number	MCN2208US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.Images were provided.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
During a maxillofacial surgery procedure ¿ bilateral tmj arthroscopy right side: wilkes iii, ac level iiic.Synovitis i, chondromalacia ii, roofing 0% to 100%, capsulotomy + toxin 25 u, disc repositioning + discopexy with 1 postero-lateral resorbable pin, bupivacaine + corticosteroids posterior subsynovial, radiofrequency coagulation, prp + ha 3 ml intra-articular.Left side: wilkes ii, ac level iib.Synovitis ii, chondromalacia ii, roofing 90%, toxin 25 u to the pterygoid muscle, bupivacaine + corticosteroids posterior subsynovial, radiofrequency coagulation, prp + ha 2 ml intra-articular.These needles were used in the surgical field, and metallic fragments were observed to detach during needle withdrawal, which then had to be removed.There are 2 medical device reports for this event.This report is for the first lot number.

• Brand Name: CHIBA BIOPSY NEEDLE WITH ECHOGENIC TIP 22GA X 20CM
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75758
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 24285877
• Report Number: 0001625425-2026-00933
• Device Sequence Number: 21297611
• Product Code: KNW
• UDI-Device Identifier: 00886333001873
• UDI-Public: (01)00886333001873(17)290926(10)11590317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: MCN2208US
• Device Lot Number: 11590317
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/07/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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