MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA; FOOT-SWITCH, ELECTRICAL

Model Number 225023

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi:(b)(4).Incomplete.The lot number is unknown at this time.

Event Description

It was reported via complaint submission tool that during a rotator cuff repair the coagulation of a vapr 3 footswitch would not activate, it was confirmed that the ablate foot pedal button was working.They exchanged out for wireless foot pedal to complete procedure with a delay of 5 minutes.No patient consequences reported.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that during a rotator cuff repair the coagulation of a vapr 3 footswitch would not activate, it was confirmed that the ablate foot pedal button was working.The complaint device was received and inspected.Visual observations reveals the device is worn as it has marks of wear.Besides, the cable was damage; it was slightly broken.To test its functionality, the device was connected to a vapr vue generator and was set to maximum power for ablation and coagulate modes as a result when active the blue pedal the device did not work; in consequence, the device did not coagulate.Therefore, this complaint can be confirmed.The possible root cause for the cord damage can be related to as rough use by the user.Also, for the issue reported could be attributed to fair wear and tear; also, as age of the device.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and 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.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d4: the lot number was reported as unknown on the initial report.It has been updated as 1807150; therefore, udi: (b)(4).

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that during a rotator cuff repair the coagulation of a vapr 3 footswitch would not activate, it was confirmed that the ablate foot pedal button was working.The complaint device was received and inspected.Visual observations reveals the device is worn as it has marks of wear.Besides, the cable was damage; it was slightly broken.To test its functionality, the device was connected to a vapr vue generator and was set to maximum power for ablation and coagulate modes as a result when active the blue pedal the device did not work; in consequence, the device did not coagulate.Therefore, this complaint can be confirmed.The possible root cause for the cord damage can be related to as rough use by the user.Also, for the issue reported could be attributed to fair wear and tear; also, as age of the device.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and 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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10643770
• MDR Text Key: 210408764
• Report Number: 1221934-2020-02900
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: 10886705009114
• Combination Product (y/n): N
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225023
• Device Catalogue Number: 225023
• Device Lot Number: 1807150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 10/16/2020
• Patient Sequence Number: 1