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

Catalog Number 282114

Device Problems Accessory Incompatible (1004); Poor Quality Image (1408); Suction Failure (4039)

Patient Problem Not Applicable (3189)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the sales rep via cst that during two cases the fms gave great visibility during all other parts of the procedure, but visibility become poor due to bleeding and suction issues during the acromioplasty.The sales rep was using the pump is duo mode with interface cable.The blue light was functioning on the interface cable when the shaver was activated.It¿s almost as if the interface cable wasn¿t reading the dyonic¿s shaver.A 3 minutes delay was reported.The procedure was completed with the same device.Fluid extravasation of the shoulder joint was also reported.No other information was provided.Additional information received from the affiliate reporting the device will not be returning for evaluation.

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11: b1, b2, b5, h1: the device has been re-assessed and it is non-reportable.The patient harm is related to the pump and is reported on mfr number 1221934-2019-58787.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The device has been re-assessed and it is non-reportable.The patient harm is related to the pump and is reported on mfr number 1221934-2019-58787.

• 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: 9151365
• MDR Text Key: 167629067
• Report Number: 1221934-2019-58786
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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?: No
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1