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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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DEPUY MITEK LLC US FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284002
Device Problem Suction Failure (4039)
Patient Problem Not Applicable (3189)
Event Date 10/25/2018
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 an unspecified surgical procedure of the shoulder, it was observed that the fms vue pump's shaver interface cable function was not allowing outflow.It was reported that there was a five minute delay and no patient harm.Another mitek device was utilized to complete the surgery.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
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.The complaint device was received and evaluated at service center.Per service manual operational and diagnostic analysis does not confirm the reported issue (shaver interface cable function is not allowing outflow), unit was tested with 2 different interface cable and no issue found.However, replaced suction pressure arm and door mounting post due to locking up issue.Replaced worn fingers on pressure arm housing (preventive maintenance) with tip replacement kit.Per sb, performed software upgrade to 3.11.And performed cpld version upgraded to 1.7 (see form in attachments).The testing of the unit was completed per the service manual.The unit passed all functional tests and is fully operational.No further investigation beyond what is noted above will be conducted on this complaint.We cannot determine a root cause for why the customer experienced the reported problem.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the records reviewed.At this 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.
 
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 dfa.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.Awaiting dhr.Awaiting wo to be closed.At this 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.Related complaints search was not performed per nr-0109218 udi:(b)(4).
 
Event Description
Additional information received on 11/15/2018 stated that the product was shipped back.The affiliate stated, "not sure as to location now but proper protocol was followed on return.".
 
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 dfa.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.Udi: (b)(4).
 
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Brand Name
FMS VUE PUMP
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8069670
MDR Text Key127217860
Report Number1221934-2018-55284
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020591
UDI-Public10886705020591
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,health
Type of Report Initial,Followup,Followup,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Date Manufacturer Received12/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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