MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS CONNECT (VUE); ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number 282114

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a shoulder arthroscopy procedure on (b)(6) 2021, it was observed that the fms connect interface cable vue device had no suction.Another like device was used to complete the procedure.There were no patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information received, the fms connect interface cable vue would not suction.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual analysis of the returned device, determined that there¿s no physical damage in the device.Testing of the device functionality revealed that that the shaver was detected, the fms vue interface cable and shaver were connected and recognized by the pump.In addition, one remote control was connected to the pump, as result, the function of the suction was working without issues as expected, the device was tested several times to ensure the proper functioning.A manufacturing record evaluation was performed for the finished device lot number:h37a41215, and no non-conformances were identified.The customer complaint cannot be confirmed.Based on the information currently available.Product evaluation of the returned device indicates that the any defect were found.In this case, it can be concluded that root cause of the failure reported is due to an incorrect connection of the equipment, however; it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications at this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FMS CONNECT (VUE)
• Type of Device: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11344354
• MDR Text Key: 232552895
• Report Number: 1221934-2021-00578
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020485
• UDI-Public: 10886705020485
• Combination Product (y/n): N
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2021

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
• Device Operator: Health Professional
• Device Model Number: 282114
• Device Catalogue Number: 282114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/03/2021; 03/24/2021
• Supplement Dates FDA Received: 03/04/2021; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1