MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS CONNECT (VUE); FOOT-SWITCH, ELECTRICAL

Catalog Number 282114

Device Problem Intermittent Continuity (1121)

Patient Problem Not Applicable (3189)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).

Event Description

It was reported by the affiliate that the caller reported that before an unknown procedure the fms interface connect cable (vue) is out of order.Another device was used to complete the case with no harm on the patient reported but there was a less than 10 minute delay reported.The caller mentioned it didn't want to send it for repair but wanted a new one.Additional information received from the affiliate reporting a 10 minute surgical delay with no patient consequence.The affiliate also reported that the surgeon was able to complete the procedure with an arthropump interface.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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: the device was received visually inspected and evaluated.No anomalies were found upon visual evaluation.The device was connected to a vapr vue generator.The blue led light indicated the device is receiving power.The led light also blinked when the shaver was activated.Upon operation of the shaver, the pinch valve did not activate.The complaint is confirmed.The potential root cause could be attributed to a defective electronic component.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.At this point, 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.Udi: (b)(4).

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.

• Brand Name: FMS CONNECT (VUE)
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8649441
• MDR Text Key: 146350977
• Report Number: 1221934-2019-57204
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020485
• UDI-Public: 10886705020485
• Combination Product (y/n): N
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 282114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/31/2019; 07/30/2019
• Supplement Dates FDA Received: 06/26/2019; 07/30/2019
• Patient Sequence Number: 1