MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number	360-1080-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this product family was conducted.Historically, no deviations or non-conformance's that would lead to this issue were found.A fragment of the tip of the device was returned from the customer for review.The actual device was not returned.A visual inspection was performed on the fragment, and it appears to be one of the three tips from the cutting cannula.The complaint was confirmed.There are stringent computer and photographic inspections that ensure the cannula tri-tips are not deformed or broken during the manufacturing process.The tri-tip damage was possibly caused by the device striking a hard external surface or an interference with a coaxial, if one was used.Since the actual device that the fragment came from was not provided, a more thorough investigation could not be performed.No corrective action can be implemented at this time.A review of the complaints database was conducted.Over the previous six months, no similar complaints were found related to this product family and no similar complaints related to part number.A lot number was not provided to review.
Event or Problem Description
Breakage of a biopince breast biopsy needle during biopsy on (b)(6) 2024 without this being noticed by the doctor.A metal fragment remained in the left breast until 10 june, when it was expelled.The doctor checked following removal with a mammogram to ensure there was no metallic in the left breast.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19812709
• Report Number: 0001625425-2024-01069
• Device Sequence Number: 8670975
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 360-1080-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female