MAUDE Adverse Event Report: HOLOGIC, INC ATEC 0912-12; INSTRUMENT, BIOPSY

Model Number	ATEC 0912-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024 a physician reported that sometimes when performing a biopsy with an atec needle they noticed a piece of material plastic in between the specimens.Physician provided a picture in which it can be observed a plastic particle mixed along with the samples.The particles were only observed in the samples and not in the patients.No samples have been observed in the breast of the patient.Physician reported that no injury was reported to patients nor users.No other information available.
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.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that on (b)(6) 2024, a physician reported that sometimes when performing a biopsy with an atec needle they noticed a piece of material plastic in between the specimens.Physician provided a picture in which it can be observed a plastic particle mixed along with the samples.The particles were only observed in the samples and not in the patients.No samples have been observed in the breast of the patient.Physician reported that no injury was reported to patients nor users.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted, and the complainant sent a bottle with a sample that looks like a plastic piece, as evidence of the foreign material.During the visual inspection the cut block was found not to be damaged, no damage or broken parts were detected, however, damage in the protective sheath was found.This damage was reviewed under magnification and noticed that the shape matches with the particle that was sent.Functional testing was not conducted.As additional information, the particle was chemically analyzed and according to the analysis records provided, the particle matches with the composition that the protective sheath is made.The complaint was confirmed, and root cause analysis determined that the failure was attributable to foreign material coming from the protective sheath.This issue was most probably related to user error and/or customer technique regarding warnings and precautions section of the ifu quotes ¿avoid operator or instrument contact with the sheathed needle portion of the atec breast biopsy device¿ and ¿the biopsy procedure should be performed only by persons having adequate training and familiarity with this procedure¿.Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.The investigation suggests this is not a recurring issue within the product family, system, or failure mode referenced in the complaint.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.Lot number e23k27ra.Expiration date 26-oct-2025.Manufacture date 27-oct-2023.Udi (b)(4).
Additional Manufacturer Narrative
Additional investigation information: an investigation was conducted: it was reported that on (b)(6) 2024, a physician reported that sometimes when performing a biopsy with an atec needle they noticed a piece of material plastic in between the specimens.Physician provided a picture in which it can be observed a plastic particle mixed along with the samples.The particles were only observed in the samples and not in the patients.No samples have been observed in the breast of the patient.Physician reported that no injury was reported to patients nor users.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted, and the complainant sent a bottle with a sample that looks like a plastic piece, as evidence of the foreign material.During the visual inspection the cut block was found not to be damaged, no damage or broken parts were detected, however, damage in the protective sheath was found.This damage was reviewed under magnification and noticed that the shape matches with the particle that was sent.Functional testing was not conducted.As additional information, the particle was chemically analyzed and according to the analysis records provided, the particle matches with the composition of the protective sheath.The complaint was confirmed, and root cause analysis determined that the failure was attributable to foreign material coming from the protective sheath.A replication was performed, and it was established that the issue is most likely due to incorrect removal of the protective sheath from the device cannula, which results in shaving the tip of the sheath.This issue was most probably related to user error and/or customer technique.Warnings and precautions section of the ifu indicates ¿avoid operator or instrument contact with the sheathed needle portion of the atec breast biopsy device¿ and ¿the biopsy procedure should be performed only by persons having adequate training and familiarity with this procedure¿.The investigation involved a comprehensive review of device history records, ifu, complaint data, risk assessments, and testing results.Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.No new capa, hra, ncr, or scar are deemed required at this moment based on this event future events will be monitored and trended.Complaint confirmed: yes.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 0912-12
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21233057
• Report Number: 1222780-2025-00037
• Device Sequence Number: 8630430
• Product Code: KNW
• UDI-Device Identifier: 15420045504851
• UDI-Public: (01)15420045504851(17)251026(10)E23K27RA
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 10/26/2025
• Device Model Number: ATEC 0912-12
• Device Catalogue Number: ATEC 0912-12
• Device Lot Number: E23K27RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 02/03/2026
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 11/06/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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