MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR 2.3MM SHORT SIDE EFFECT ELECTRODE; ELECTROSURGICAL: CUTTING AND COAGULATING

Catalog Number 225211

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

It was reported that during arthroscopic surgery for tmj the black coating of the shaft of the device came off without excessive force.The broken piece came out during perfusion and nothing was left in the patient¿s body.No surgical delay or harm to the patient was reported.The backup device was used to complete the case.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.

Manufacturer Narrative

The complaint device was received and examined under magnification.The insulation coating is cut and peeled in the received devices, confirming this complaint.Visual observations also revealed multiple nicks and marks on the shaft consistent with coming into contact with sharp metal instruments.The electrode¿s shaft was slightly bent; indicating mishandling.Moreover, the device has tissue debris around the tip.This type of failure has been attributed to instrument coming in contact with other instruments that produce heat during operation or sharp edges causing the insulation layer to be cut.Other than this possibility, we cannot determine a root cause for this failure mode.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point, no further action is warranted.However, depuy synthes 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.

Event Description

It was reported that during arthroscopic surgery for tmj the black coating of the shaft of the device came off without excessive force.The broken piece came out during perfusion and nothing was left in the patient's body.No surgical delay or harm to the patient was reported.The backup device was used to complete the case.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In process.

Event Description

It was reported that during arthroscopic surgery for tmj the black coating of the shaft of the device came off without excessive force.The broken piece came out during perfusion and nothing was left in the patient's body.No surgical delay or harm to the patient was reported.The backup device was used to complete the case.

• Brand Name: MITEK VAPR 2.3MM SHORT SIDE EFFECT ELECTRODE
• Type of Device: ELECTROSURGICAL: CUTTING AND COAGULATING
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4851065
• MDR Text Key: 5870193
• Report Number: 1221934-2015-00834
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 225211
• Device Lot Number: U1411022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/21/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2015
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1