MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR ARCTIC ELECTRODE-CHISEL; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement- the complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Dhr review; part number: 225030; supplier lot number: u1603055; release to warehouse date: 4/5/16; manufacturing date: 3/30/16; expiration date: 5/31/17; supplier: (b)(4); manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
It was reported that during a hip scope the tip of electrode broke and bending mechanism wouldn¿t work anymore.Another electrode to complete the procedure.There were no patient consequences.

• Brand Name: VAPR ARCTIC ELECTRODE-CHISEL
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8288557
• Report Number: 1221934-2019-56252
• Device Sequence Number: 1912196
• Product Code: GEI
• UDI-Device Identifier: 10886705022519
• UDI-Public: 10886705022519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 225030
• Device Lot Number: U1603055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2016
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1