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

Catalog Number	283551
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Evaluation statement: the complaint device was received and evaluated.Visual observation revealed no anomalies with the device.The device was set up with an fms duo pump and the hand piece was operated in forward, reverse, and oscillation modes.The speed button worked intermittently but the other buttons displayed continuous function.We can confirm this complaint but cannot discern a root cause for the user to have experienced this failure.A batch record review has been conducted and 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 mitek complaints system revealed no other complaints from this lot released for distribution in 2014.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during an unspecified surgical procedure of the shoulder that the customer's remote control was working intermittently causing the pump to go on and off by itself.The surgeon completed the procedure with another like device with no patient consequences.There was a five minute delay in the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 8281706
• Report Number: 1221934-2018-54465
• Device Sequence Number: 16470540
• Product Code: HRX
• UDI-Device Identifier: 10886705016990
• UDI-Public: 10886705016990
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2015
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1