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

Model Number	MRU11X
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/14/2017
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 for conduct of a breast tissue biopsy procedure.One mru11x was received on may 9th, 2017 and analyzed on may 12th, 2017.The device showed signs of being used in a procedure.The obturator was observed to be broken.A piece was found in the damaged end of the plastic obturator sleeve.The obturator sleeve is bent at a 90 degree angle at the location of the open aperture.The tip of the broken obturator was observed to be missing the sharp end.The investigation is ongoing.Follow-up with the treating physician confirmed that the broken obturator tip was removed during surgery on (b)(6) 2017.Based on the patient consequence of the unintended piece of the device in the biopsy site, the additional surgical procedure to remove, and pursuant to 21 cfr 803 this is a reportable event.Thus, we are submitting this medwatch report.
Event or Problem Description
The sales rep reported that the "obturator broke at proximal end of aperture.The needle bent in the patients breast and caused the tip to shear off leaving a piece in the patients breast.
Additional Manufacturer Narrative
Additional investigation determined that the surgeon's technique caused the reported event.The surgeon's technique includes placing the targeting set into the breast just about 1cm, then inserting the cube into grid unintentionally causing a fulcrum to occur on the proximal end of the aperture.This can occur more easily if the tip is in an upward angle when the cube is being pressed into the grid.The surgeon's current technique does not follow ifu instructions which 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.Using a targeting set from another lot, and following the surgeon's technique, the event was duplicated.On (b)(6) the doctor was retrained on the proper steps for preparing the mammotome mr targeting set.Date of this report was updated to reflect the date the investigation was concluded.Type of report was update to reflect that this reporte is a follow-up report.Even problem was updated to remove (b)(4).
Event or Problem Description
The sales rep reported that the "obturator broke at proximal end of aperture.The needle bent in the patients breast and caused the tip to shear off leaving a piece in the patients breast.

• 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: 6565092
• Report Number: 3008492462-2017-00032
• Device Sequence Number: 10902055
• Product Code: KNW
• UDI-Device Identifier: 00841911101116
• UDI-Public: (01)00841911101116(17)220221(10)F11707482D
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K042753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 02/21/2022
• Device Model Number: MRU11X
• Device Catalogue Number: MRU11X
• Device Lot Number: F11707482D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other