MAUDE Adverse Event Report: COOK INC KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE; MIJ NEEDLE, TUMOR LOCALIZATION

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient underwent a breast excision on (b)(6) 2016 with placement of a kopans modified breast lesion localization needle.The patient presented to the clinic on (b)(6) 2017 with a complaint that a section of the wire came out of her breast.The surgical site was examined and reportedly "everything is fine and no infection" was found.The patient gave the externalized section of the needle to the physician.The circumstances and handling of the device for two months post breast excision are not known.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The customer returned only the hookwire component of a kopans modified breast lesion localization needle; the needle portion of the device was not returned.The hookwire was returned in a used condition.Initial visual inspection confirmed that some biomatter was present on the device.A portion of the wire was broken off and was not returned with the device.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "precautions: the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for localization of breast lesions should be employed.Following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement.Final hookwire position should be confirmed by an appropriate imaging modality.Instructions for use: 1.Introduce the needle into the lesion.2.Check the position of the needle.3.Advance and release the hookwire.4.Remove the needle.5.Bend the hookwire protruding from the breast and tape flat to the skin.6.Verify final hookwire position." based on the information provided, examination of the returned partial product and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
Corrected information: (b)(4).Additional device failure analysis (sem and optical microscopy surface fracture analysis) was completed.A surface fracture analysis was completed which included optical microscopy and scanning electron microscopy (sem).The examination revealed that it was highly probable that fracture was initiated by direct impact from a surgical tool/instrument.This resulted in necking of the wire.Subsequently, micro voids (dimples) formed and caused the crack to propagate in the direction normal to the tensile axis and, finally, cracks rapidly propagated through the periphery along the shear plane resulting in fracture termination by means of ductile fracture.The initial impact/damage hypothesized to be from an external tool increased the likelihood of crack propagation and lowered the amount of force needed to break the wire.Based on the provided information and microscopic examination, the definitive root cause was determined to be product use or handling related (user technique).The wire fracture was concluded to have been initiated by direct impact from a surgical tool/instrument during the excision procedure.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
• Common Device Name: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6427462
• Report Number: 1820334-2017-00542
• Device Sequence Number: 13696809
• Product Code: MIJ
• UDI-Device Identifier: 00827002025868
• UDI-Public: (01)00827002025868(17)210912(10)7264651
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2017

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 Model Number: N/A
• Device Catalogue Number: DKBL-20-5.0-A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided; 12/06/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 06/15/2017; 12/22/2017
• 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; Required Intervention