MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME MR UNIVERSAL TARGETING SET; BIOPSY INSTRUMENT

Model Number	MRU08X
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mammotome mr targeting set consists of a cradle, a sleeve mount assembly, and an obturator/stylet for accurate probe placement used to perform a breast tissue biopsy procedure.The device has not been returned for evaluation, which prevents a full investigation and analysis of the root cause at this time.X-ray image of the retained broken tip were provided and confirm the obturator proximal tip break.The instructions for use (ifu) state: insert obturator/stylet with depth markings into sleeve with z-lock; set and lock z-depth, aligning black triangle with top line of obturator/stylet; orient the cube; place cube in grid; insert targeting assembly into cube up to the z-lock.Caution: to minimize the risk of obturator breakage at the aperture, do not twist or torque the targeting set during insertion.Follow up with the radiologist at the user facility identified that he did not follow the ifu and placed the cube over the targeting set and attempted to insert the entire assembly into the grid.This can cause the targeting set to be inserted at an angle, unintentionally creating a fulcrum on the proximal end of the aperture.The patient underwent previously scheduled surgery to remove the breast lesion and obturator tip.No further complications reported.
Event or Problem Description
Devicor medical products, inc.Received a report from sales stating, legacy mr biopsy obturator broke off inside of patient's breast during mr biopsy.The patient was taken to previously scheduled surgery to have the biopsy and the tip of the obturator removed.This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME MR UNIVERSAL TARGETING SET
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8344569
• Report Number: 3008492462-2019-00008
• Device Sequence Number: 11099248
• Product Code: KNW
• UDI-Device Identifier: 00841911101093
• UDI-Public: (01)00841911101093(17)230712(10)F11827477D
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K042753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 07/12/2023
• Device Model Number: MRU08X
• Device Catalogue Number: MRU08X
• Device Lot Number: F11827477D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1