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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS CONNECT INTERFACE CABLE VUE; FOOT-SWITCH, ELECTRICAL
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DEPUY MITEK LLC US FMS CONNECT INTERFACE CABLE VUE; FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 282114
Device Problems Suction Problem (2170); Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Synthes mitek rep.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.Udi:(b)(4).
 
Event Description
It was reported by the sales rep via phone that during a shoulder arthroscopy procedure the blue light on the customer's fms vue interface connect cable lights up like it was recognizing the shaver but the pump does not do anything when the shaver is activated, suction not activating when shaver is.The procedure was completed by passing and using wall suction with no patient harm or surgical delay to the case.The device will be returning for evaluation.This complain if for one (1) fms connect interface cable vue.
 
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.The device was received and evaluated.Visual inspection reveals that the device is worn but in as expected condition.The device was taken to a lab and plugged into an fms vue pump.The shaver speed window on the pump showed 2500 in the oscillate mode.This is an indication of a defective fms connect.The shaver speed window on the pump should display a series of dashes when the device is plugged into the pump.The probable root cause is the pcb inside of the housing is defective.Other than this possibility, we cannot discern a root cause for this failure.This complaint can be confirmed.A manufacturing record evaluation was performed on (b)(6) 2019 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.A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Updated data-d10 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.
 
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Brand Name
FMS CONNECT INTERFACE CABLE VUE
Type of Device
FOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9194615
MDR Text Key207541199
Report Number1221934-2019-59010
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020485
UDI-Public(01)10886705020485
Combination Product (y/n)N
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number282114
Device Catalogue Number282114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Date Manufacturer Received11/18/2019
Patient Sequence Number1
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