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

Model Number	TRIMARK-EVIVA-13
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2021
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.
Event or Problem Description
It was reported that after deploying the biopsy site identifier, post biopsy mammography images were obtained.The radiologist noted what appears to be a metallic foreign body in the images that does not correlate to the site marker and was not seen on post biopsy imaging.The reported device has been requested to return to hologic for evaluation.
Additional Manufacturer Narrative
The reported biopsy marker was received by hologic for evaluation.A visual inspection of the device noted no missing or damaged component.The aperture indicator was oriented in the correct way and the plunger was latched to the aperture indicator.The spring was correctly seated on the pushrod end.The reported issue could not be confirmed since the device did not show any broken or missing part.

• 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: 11628666
• Report Number: 1222780-2021-00071
• Device Sequence Number: 14427904
• Product Code: NEU
• UDI-Device Identifier: 15420045503571
• UDI-Public: 15420045503571
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 12/08/2022
• Device Model Number: TRIMARK-EVIVA-13
• Device Catalogue Number: TRIMARK-EVIVA-13
• Device Lot Number: 20M08RJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1