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

Model Number	283551
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
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.Udi: (b)(4).Investigation summary: according to the information provided, it was reported by the sales rep via phone that during an unknown procedure the blood stop button of two remote controls was not working the complaint device j30ab0114, was received and evaluated.Visual inspection was performed and there¿s no damage in the device.During testing performance, the remote control was detected and recognized by the pump, the buttons for parameters of run/stop, pressure, suction, flow, speed and blood stop were found intermittent and defective.The device was tested several times to ensure the improper functioning.The customer complaint can be confirmed.The device was opened to review it internally.As result, it did not present any physical damage.The possible root cause for the reported failure can be associated to electrical deficiencies / defective components.However, this cannot be conclusive determined.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.
Event or Problem Description
It was reported by the sales rep that during an unknown procedure on 11/18/2020, it was observed that the blood stop button on the remote control device was not working.During in-house engineering evaluation, it was determined that the buttons for parameters of run/stop, pressure, suction, flow, speed and blood stop were working intermittently and defective.Another device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.

• 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: 11163804
• Report Number: 1221934-2021-00096
• Device Sequence Number: 11631028
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: 12/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1