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

Model Number	HB300-10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Premarket submission number not available/not released.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.An image of the broken device was provided by the physician which confirmed that the device was broken in pieces.Based on the image hologic is unable to traced the possible root cause specifically.
Event or Problem Description
It was reported that on (b)(6) 2024, a localizer tag was placed inside the breast and the localizer tag was giving off weird readings from the beginning and seemed erratic during the case.When the specimen was removed and the tag was x-rayed the tag looked smashed.When pathology removed the tag the metal part was broken in half.All tag was removed from the patient.No additional information available.
Additional Manufacturer Narrative
Visual inspection was conducted, we only received the tag, and it was completely broken.Functional testing was conducted, the loop probe did not read the tag.Hence, the complaint can be confirmed.This observation will be monitored and trended.

• Brand Name: LOCALIZER
• 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: daniel guevara ; 562 parkway; alajuela 20102
• MDR Report Key: 20527399
• Report Number: 1222780-2024-00392
• Device Sequence Number: 9171579
• Product Code: NEU
• UDI-Device Identifier: 00855436007129
• UDI-Public: (01)00855436007129(17)280320(10)53116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: HB300-10
• Device Lot Number: 53116
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female