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

Model Number	TRIMARK TD 13MR
Medical Device Problem Codes	Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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, during a biopsy procedure, when placing the biopsy marker the radiologist deployed the marker as usual.When the marker device was removed from the breast it was noted the marker was stuck in the aperture.Redeployment was not attempted.No injury reported.

• 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: 12122419
• Report Number: 1222780-2021-00197
• Device Sequence Number: 3966013
• Product Code: NEU
• UDI-Device Identifier: 05420045503291
• UDI-Public: (01)05420045503291(17)210904(10)19J05RG
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 09/04/2021
• Device Model Number: TRIMARK TD 13MR
• Device Catalogue Number: TRIMARK TD 13MR
• Device Lot Number: 19J05RG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1