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

Model Number	283551
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: according to the information provided, it was reported by the healthcare professional via email that the remote control is not working.The customer did not have additional information to provide.The complaint device was received and evaluated.Visual observations reveals the device is slightly worn, the control is observed in a different color, which makes it look old.It was functionally tested with a pump several times and it revealed that the buttons for run and stop were not functioning as expected, they were jammed, including the parameters: pressure, suction, and speed.Because of this, the control was recognized, but the pump was activated with an intermittent operation.This complaint can be confirmed.The possible root cause could be an internal wear of electrical components in the buttons; as well as rough use by the user.However, this cannot be conclusively affirmed.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.Udi:(b)(4).
Event or Problem Description
It was reported by the healthcare professional via email that the remote control is not working.The device is available to be returned for evaluation.The customer did not have additional information to provide.

• 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: 10693572
• Report Number: 1221934-2020-03046
• Device Sequence Number: 19597815
• Product Code: HRX
• UDI-Device Identifier: 10886705016990
• UDI-Public: 10886705016990
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2020

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 Model Number: 283551
• Device Catalogue Number: 283551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 10/16/2020
• Patient Sequence Number: 1