MAUDE Adverse Event Report: DEPUY MITEK LLC US REMOTE CONTROL(FMS VUE/NEXTRA); FOOT-SWITCH, ELECTRICAL

Catalog Number	283551
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device is not being returned therefore not available for a physical evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for the serial number of this device.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported by the sales rep that the customer's fms vue remote control stopped working during a shoulder scope.The case was completed with another like device.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.The device was discarded.

• Brand Name: REMOTE CONTROL(FMS VUE/NEXTRA)
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7399696
• Report Number: 1221934-2018-50413
• Device Sequence Number: 13888481
• Product Code: HRX
• UDI-Device Identifier: 10886705016990
• UDI-Public: 10886705016990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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 Catalogue Number: 283551
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1