MAUDE Adverse Event Report: HOLOGIC, INC ATEC 0912-20; INSTRUMENT, BIOPSY

Model Number	ATEC 0912-20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported by the dealer that during an atec biopsy procedure on (b)(6) 2025, that "call received from the customer that they are seeing particles, after the biopsy procedure.We went there and isolated the particle.It is a hard material probably some part of the needle." it is reported that the procedure was completed with the same device and no harm to the patient or user was reported.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the dealer that during an atec biopsy procedure on (b)(6) 2025, that "call received from the customer that they are seeing particles, after the biopsy procedure.We went there and isolated the particle.It is a hard material probably some part of the needle." it is reported that the procedure was completed with the same device and no harm to the patient or user was reported.No further information is currently available.The device was not returned to the post market quality laboratory for investigation.Visual and functional inspection could not be conducted.Root cause analysis did not identify the most probable root cause.The investigation included a comprehensive review of device history records, complaint data, risk assessments, and visual testing results.Biocompatibility testing on the atec disposable device, where the protective sheath components were tested and proved as safe meaning that no potential adverse reactions or harms are expected in the patients after the normal use of the atec device.Additionally, atec breast biopsy device instructions for use (ifu), contains in the warnings and precautions section the following statement regarding sheathed portion of the needle ¿avoid operator or instrument contact with the sheathed needle portion of the atec breast biopsy device¿.Further, on the same page, the ifu specifies the following regarding the use of product: ¿the biopsy procedure should be performed only by persons having adequate training and familiarity with this procedure.¿ both of those statements reflect the need of the right technique, to avoid damage to the protective sheath during the removal of it.Conclusion: the reported issue has not been confirmed.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.

• Brand Name: ATEC 0912-20
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23708469
• Report Number: 1222780-2025-00613
• Device Sequence Number: 21481607
• Product Code: KNW
• UDI-Device Identifier: 15420045504868
• UDI-Public: (01)15420045504868(17)270114(10)E25A14RA
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: ATEC 0912-20
• Device Catalogue Number: ATEC 0912-20
• Device Lot Number: E25A14RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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