MAUDE Adverse Event Report: Hologic, Inc. TRIMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TRIMARKTD-2S-13-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that, "during biopsy, radiologist tried to deploy marker.Device shot off like a gun.It deployed the marker, but looks like the metal on inside exploded." customer outreach confirmed that "metal was sticking out of the side of aperture/hole area" and that this was "only identified when removed from the breast." despite the reported issue, the marker was successfully deployed and the procedure was completed using the same device.No patient or user harm was reported, and no additional medical or surgical intervention were required due to this issue.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.Investigation is ongoing.

• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50802636
• Report Number: 1222780-2026-00601
• Device Sequence Number: 8653489
• Product Code: NEU
• UDI-Device Identifier: 05420045503338
• UDI-Public: (01)05420045503338(17)280223(10)E26B23RH
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Model Number: TRIMARKTD-2S-13-12
• Device Catalogue Number: TRIMARKTD-2S-13-12
• Device Lot Number: E26B23RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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