MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOMARK; MAMMOMARK BIOPSY SITE IDENTIFIER 10G - U-SHAPE - NON-CE

Model Number	MMK1002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporter, there was a tip shear of mmk1002 marker.The tip was left inside of the breast and discovered in post-biopsy imaging.Radiologist confirmed that the aperture was fully open during deployment.The problem occurred during the procedure.The procedure was completed with the reported mmk1002.No patient complications were noted.Additional follow up determined that the patient will decide at a later date if there will be a surgical removal of the tip.The device was not returned.The most likely root cause was determined to be customer failure to follow instructions for use.The instructions for use for this device states: "the marker applicator may be sheared off resulting in a piece left behind in the patient.The probability of a tip shear may increase as a result of: · removing or rotating the marker applicator independently from the probe." and "remove the hydromark¿ applicator and the mammotome® revolve¿ biopsy probe together as a single unit from the site".
Event or Problem Description
According to the reporter, there was a tip shear of mmk1002 marker.The tip was left inside of the breast and discovered in post-biopsy imaging.Radiologist confirmed that the aperture was fully open during deployment.The problem occurred during the procedure.The procedure was completed with the reported mmk1002.No patient complications were noted.
Additional Manufacturer Narrative
The initial report was submitted on 15-oct-2025.H11 had the incorrect information in paragraph #2.The purpose of this report is to correct h11 from the initial report.The device was not returned.The most likely root cause was determined to be customer failure to follow instructions for use.The instructions for use for this device states: "caution: do not insert beyond appropriate band or tip damage may occur" and "caution: do not activate the probe cutter or other clinical functions while a marker is inserted in the probe.Take care to completely remove the marker out of the probe before activating any of the holster's clinical functions.".

• Brand Name: MAMMOMARK
• Common Device Name: MAMMOMARK BIOPSY SITE IDENTIFIER 10G - U-SHAPE - NON-CE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; tijuana, bc 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241 ; 5138649047
• MDR Report Key: 23280209
• Report Number: 3008492462-2025-00024
• Device Sequence Number: 20210304
• Product Code: NEU
• UDI-Device Identifier: 00841911101628
• UDI-Public: (01)00841911101628(17)270201(10)F12531549D
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MMK1002
• Device Lot Number: F12531549D
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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
• Patient Sex: Unknown