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

Model Number	MMK1003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, there was a tip shear of mmk1003.The radiologist noticed the tip shear before the stereotactic biopsy was finished and was able to remove the tip before completion of the procedure.Radiologist confirmed that the aperture was fully open during marker deployment.Per the account, "the radiologist noticed the plastic piece when we took the image when he was placing the marker.He changed the direction of the probe, and we took another image, and the plastic was back in the marker device".The problem occurred during the procedure.The procedure was completed with the reported mmk1003.No patient complications were noted.
Additional Manufacturer Narrative
According to the reporter, there was a tip shear of mmk1003.The radiologist noticed the tip shear before the stereotactic biopsy was finished and was able to remove the tip before completion of the procedure.Radiologist confirmed that the aperture was fully open during marker deployment.Per the account, "the radiologist noticed the plastic piece when we took the image when he was placing the marker.He changed the direction of the probe, and we took another image, and the plastic was back in the marker device".The problem occurred during the procedure.The procedure was completed with the reported mmk1003.The device was not returned for evaluation.Based on available information and user feedback, the most likely root cause was determined to be customer failure to follow the instructions for use (ifu).The ifu clearly states: "caution: do not insert beyond appropriate band or tip damage may occur." "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." failure to adhere to these precautions may have contributed to the reported issue.No device fragments remained in the patient, and no complications were reported.If any new information becomes available, the complaint will be reassessed accordingly.

• Brand Name: MAMMOMARK
• Common Device Name: MAMMOMARK BIOPSY SITE IDENTIFIER 10G - TRIPLE TWIST - 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: 23300723
• Report Number: 3008492462-2025-00025
• Device Sequence Number: 10028270
• Product Code: NEU
• UDI-Device Identifier: 00841911100522
• UDI-Public: (01)00841911100522(17)270201(10)F12531550D
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: MMK1003
• Device Lot Number: F12531550D
• 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
• Initial Report FDA Received Date: 10/15/2025
• 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