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

Model Number	MMK1003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the affiliate that the tips of the marker (blue colour plastic) detached and remain in the patient breast.The user wants to know the material made of the plastic tip.
Additional Manufacturer Narrative
The mammomark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking.The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker.Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast.It was reported by the affiliate that the tips of the marker (blue colour plastic) detached and remain in the patient breast.The user wanted to know the material made of the plastic tip.The user was educated about the material by mammotome.To date there has been no information of permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage.

• Brand Name: MAMMOMARK
• Common Device Name: BIOPSY SITE IDENTIFIER
• 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; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian rodriguez ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 14806427
• Report Number: 3008492462-2022-00009
• Device Sequence Number: 4934545
• Product Code: NEU
• UDI-Device Identifier: 00841911100522
• UDI-Public: (01)00841911100522(17)230516(10)F12145348D
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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 Expiration Date: 05/16/2023
• Device Model Number: MMK1003
• Device Catalogue Number: MMK1003
• Device Lot Number: F12145348D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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