MAUDE Adverse Event Report: DEPUY MITEK FMS CONNECT DUO/SOLO (UIC); FOOT-SWITCH, ELECTRICAL

Catalog Number	282112
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate evaluation statement: this complaint is being closed since after multiple attempts to retrieve the product, the product still hasn't been returned for evaluation.If and when the device in question is received, this file will be reopened and its contents made to reflect the results of the evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event; 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.(b)(4)-incomplete.The lot number is currently unavailable.This report is being filed from the remetrex complaint management system 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 a rotator cuff repair, it was observed that his fms connect duo/solo (uic) was not communicating consistently with the pump.The sales rep reported that the surgeon completed the procedure by unplugging and resetting the device numerous times.The sales rep confirmed that there were no patient consequences but there was a five minute delay.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: FMS CONNECT DUO/SOLO (UIC)
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7767194
• Report Number: 1221934-2018-53384
• Device Sequence Number: 19459804
• Product Code: HRX
• UDI-Device Identifier: 10886705020478
• UDI-Public: 10886705020478
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K130169
• 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): 03/27/2015

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 282112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2015
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1