MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT 16GA X 10CM; INSTRUMENT, BIOPSY

Model Number	763116100X
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
A director of imaging reported "we used this biopsy device and on the post procedure mammogram, the radiologist noticed linear/metallic artifact near the clip that was deployed.They believe this came from the biopsy device.Mammotme hydromark placed after biopsy.".
Additional Manufacturer Narrative
A comprehensive review of the manufacturing and inspection records for this lot was completed, and no deviations or non-conformances were observed.Although the specific device used in the reported incident was not returned for evaluation, nineteen unopened devices from the same lot were provided and subsequently assessed.Each of these devices was opened and test fired ten times, with no issues identified.The needle sets were then carefully removed and evaluated for proper functionality, all of which operated as intended.Finally, the empty handles were test fired an additional five times to check for potential concerns such as loose components, and no anomalies were found.As the used device was not returned and all nineteen unopened devices from the same lot were thoroughly evaluated with no issues identified, a definitive root cause could not be determined.At this time, no corrective actions are deemed necessary.However, should the used device become available in the future, we would gladly revisit the complaint for further assessment.Additional information provided in h3, h6 and h11.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 16GA X 10CM
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 21892461
• Report Number: 0001625425-2025-00994
• Device Sequence Number: 19693588
• Product Code: KNW
• UDI-Device Identifier: 00886333006618
• UDI-Public: (01)00886333006618(17)291127(10)11599259
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K982960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 763116100X
• Device Lot Number: 11599259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White