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	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: according to the information provided, it was reported that during a rotator cuff repair the remote controls failed.The complaint device was received and evaluated.Visual inspection was performed and there¿s no damage in the device.During testing performance, the remote control was connected in the pump and the buttons did not respond properly due to showed intermittence in their operation.The device was tested several times to ensure the improper functioning.The customer complaint can be confirmed.The possible root cause for the reported failure can be attributed to internal electrical deficiencies / defective components.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device serial number: (b)(4), and no non-conformances were identified.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 sales rep via phone that during a rotator cuff repair the remote controls failed.The circulating nurse manually adjusted the pressure on the pump as needed to complete the procedure.No patient consequences, or surgical delay reported.The devices are available to be returned for evaluation.

• 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: 10607220
• Report Number: 1221934-2020-02812
• Device Sequence Number: 2940767
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/30/2020
• Patient Sequence Number: 1