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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
Model Number 284002
Device Problem Mechanical Jam (2983)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: the device was received at the service center and evaluated. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. This complaint can be confirmed. It was found during evaluation that the fill button's led was not illuminating. Also, there was locking up issue identified. Further, worn fingers were observed on the pressure arm housing. The bezel & membrane switch, worn fingers and left follower arm assembly were replaced to resolve the issues. Preventive maintenance was also performed. After repair, the device was found to be working according to the specifications. The defective left follower arm assembly would have caused the observed locking up issue. With the available information, we cannot determine the root causes of the other identified failures. A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances related to the reported complaint condition 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.
 
Event Description
It was reported that the pump had an unspecified malfunction. During in-house engineering evaluation, it was determined that there was locking up issue identified on the left follower arm assembly on the device. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use. There were no reports of any injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key10504687
MDR Text Key207916222
Report Number1221934-2020-02413
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284002
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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