MAUDE Adverse Event Report: ARGON MEDICAL DEVICE BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM

Model Number	360-2080-01
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot number was conducted, and no deviations or non-conformances relevant to the complaint were recorded.This lot number, as given, does not match the part number, as given.The procedure in the complaint, as given, indicates that a 360-2080-01 biopince fullcore biopsy instrument 18g x 20cm (part number) and/or a mcxs1810bp co-axial needle 18g x 10cm (lot number) was used in a bone biopsy procedure, and broke during the procedure.The biopince line is designed to be used in soft tissue.No response was given after three attempts to reach out and clarify the information provided.According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.
Event or Problem Description
Scheduled ct guided bone marrow aspirate and core under monitored anesthesia care was in progress.The right iliac bone was accessed with an introducer needle and a 1 cm distal tip of the outer cannula of the co-axial introducer needle broke off and was left retained deep within the right iliac bone.The risks of removing the foreign body outweighed the benefit of leaving it in and decision was made to leave the foreign body in place.Case proceeded to conclusion with no additional patient harm or event.Device was not saved for evaluation by biomedical but packaging information retained.What problem did the user have (check all that apply) : device malfunction that is, the device did not do what it was supposed to do.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICE; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: gedaa hassan ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 12684127
• Report Number: 0001625425-2021-01104
• Device Sequence Number: 14961729
• Product Code: KNW
• UDI-Device Identifier: 00886333004348
• UDI-Public: 00886333004348
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 360-2080-01
• Device Catalogue Number: 360-2080-01
• Device Lot Number: 11367482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown