MAUDE Adverse Event Report: HOLOGIC, INC TRIMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TRIMARK TD 1309
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that after a vacuum assisted breast biopsy, using an atec needle and trimark breast marker, no marker was observed in the patient's breast tissue in the post procedure mammogram.It is reported that the marker deployment procedure was not completed.No patient or user harm was reported.

• Brand Name: TRIMARK
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• 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: 24562651
• Report Number: 1222780-2026-00109
• Device Sequence Number: 10114768
• Product Code: NEU
• UDI-Device Identifier: 15420045503274
• UDI-Public: (01)15420045503274(17)260321(10)E24C21RP
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K023450
• 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
• Report Date (Section B): 03/10/2026

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: 03/21/2026
• Device Model Number: TRIMARK TD 1309
• Device Catalogue Number: TRIMARK TD 1309
• Device Lot Number: E24C21RP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• 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 Sex: Unknown