MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOMARK; MAMMOMARK BIOPSY SITE IDENTIFIER 10G BOWTIE

Model Number	MMK1001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that the applicator tip sheared off in the breast after the marker was deployed.The mammomark was placed during an upright st procedure using the revolve 10g probe.The marker applicator tip was visible outside the biopsy cavity in the post-procedure image.The marker applicator has been discarded.At the time the complaint was recieved it was undecided if any surgical intervention would take place.To date no new infomation regarding additional surgery has been recieved.Patient has not experienced any adverse reactions related to the object.No additional patient complications were noted.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.If any new information becomes available, the complaint will be reassessed accordingly.
Event or Problem Description
The customer reported that the applicator tip sheared off in the breast after the marker was deployed.The mammomark was placed during an upright st procedure using the revolve 10g probe.The marker applicator tip was visible outside the biopsy cavity in the post-procedure image.The marker applicator has been discarded.

• Brand Name: MAMMOMARK
• Common Device Name: MAMMOMARK BIOPSY SITE IDENTIFIER 10G BOWTIE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnatii 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; cincinnati, OH 45241
• MDR Report Key: 25229170
• Report Number: 3008492462-2026-00008
• Device Sequence Number: 10237887
• Product Code: NEU
• UDI-Device Identifier: 00841911102724
• UDI-Public: (01)00841911102724(10)F12608307D(17)290218
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: MMK1001
• Device Lot Number: F12608307D
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2026
• 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: Required Intervention
• Patient Sex: Unknown