MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK; BIOPSY SITE TISSUE MARKER DEVICE

Model Number	TRIMARK 36-09
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that when deploying the marker there was no marker in the biopsy cavity."we investigated the deployment device and nothing was found in side the device neither".No injury or misdiagnosis was reported.
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The reported device was received, but could not be tested.Clinically used and latched device was returned and occluded with dried blood and the trap door was bent open.No marker was present in device window.The latched plunger rod could not be freed for testing due to dried blood.

• Brand Name: TRIMARK
• Common Device Name: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8460803
• Report Number: 1222780-2019-00067
• Device Sequence Number: 2818776
• Product Code: NEU
• UDI-Device Identifier: 15420045503304
• UDI-Public: 15420045503304
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2019

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: 08/16/2020
• Device Model Number: TRIMARK 36-09
• Device Catalogue Number: TRIMARK 36-09
• Device Lot Number: 18H17RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019; 03/07/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/21/2019; 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1