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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP-SHAVER BOX; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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DEPUY MITEK LLC US FMS VUE PUMP-SHAVER BOX; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problem Increase in Pressure (1491)
Patient Problem Extravasation (1842)
Event Date 11/11/2020
Event Type  Injury  
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 affiliate in (b)(6) that during a rotator cuff repair procedure on (b)(6) 2020, it was observed that the flow from the fms vue pump shave device increased dramatically 20 minutes into the surgery.According to the report, the pressure was evidently much higher than what was shown on the pump.There were 30 bags of fluid used which was twice the normal volume.The procedure was completed but the patient's shoulder looked larger than it should and was swollen.There was an unspecified minimal delay in the procedure.The status of the patient post-surgery was unknown.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.The manufacturing site name was reported as unknown on the initial report and has been updated accordingly.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.Correction narrative: the udi was inadvertently missed on the previous report.Therefore, udi: (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).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: 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.
 
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, it was reported that during a rotator cuff repair surgeon was using the fms vue 2, but 20 minutes in the flow increased dramatically and was evidently much higher than the 30 shown on the pump.Used over 30 bags of fluid, twice it¿s normal volume.This 30 is related to flow measurement but it was using fluid as if the rate was 80 plus.Procedure was completed but the patient's shoulder looked larger than it should have, it was swollen, and he had issues with the repair.The complaint device was received at the service center and evaluated.The other accessories used in the procedure were not received for evaluation.Also, mitek conducted visual inspection of video provided by customer.During evaluation by the medical system service, the reported issue cannot be duplicated, and no other fault was found.The testing of the unit was completed per the service manual, the unit passed all functional tests and is fully operational.Upon visual inspection of the video, it was identified an inadvertent leakage of fluid.Per service manual operational and diagnostic, the reported failure was not confirmed and possible root cause for the reported failure cannot be determined.The possible root cause for the condition found in the video could be related to manipulation or procedural variables, such handling of the device or product interaction during the procedure which could lead a problem with the fluid by the fms vue pump; however, it cannot be conclusively affirmed.As per ifu-115810, while using the tubing with one way valve, if additional joint pressure is created by the surgeon during joint manipulation, the pressure displayed at the pump will not reflect the pressure change.A manufacturing record evaluation was performed for the finished device 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.
 
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Brand Name
FMS VUE PUMP-SHAVER BOX
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10928718
MDR Text Key218988590
Report Number1221934-2020-03645
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705027934
UDI-Public10886705027934
Combination Product (y/n)N
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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