MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS CONNECT (VUE); FOOT-SWITCH, ELECTRICAL

Catalog Number 282114

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep that during a shoulder repair procedure, it was observed that the customer's fms vue connect interface cable stopped working.The case was completed with another like-device with no patient harm or delay.The sales rep was not present for the case and could not provide any additional information.The device is being returned for evaluation.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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Investigation summary: the complaint device was received and evaluated.Visually, the device seemed to be in good condition.No anomalies were discovered on the device.Via functional testing, the device was connected to a fms pump.The pump was powered on and the blue led light in the interface cable illuminated as expected, however a shaver speed was displayed on the pump (2500rpm), which indicates a defective device, which could've caused the reported failure.The device was reconnected to the fms pump numerous times and the same fault occurred.The device does not function as intended when the shaver speed is shown, therefore no further testing could be conducted.This complaint is confirmed.Possible root cause for this type of failure could be a damage component anywhere in the electrical path from the fisher connector to the fms connect.I.E.Broken solder joint or internal cable break, however a specific root cause could not be determined, as the circuit board is potted so it¿s not possible to disassemble and troubleshoot the pcb.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Additional information: concomitant medical products, device evaluated by mfr: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: FMS CONNECT (VUE)
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8179629
• MDR Text Key: 131002265
• Report Number: 1221934-2018-55758
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

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 Catalogue Number: 282114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 01/03/2019
• Supplement Dates FDA Received: 01/09/2019; 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1