MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC

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.

• 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
• 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 Key: 10504687
• MDR Text Key: 207916222
• Report Number: 1221934-2020-02413
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• 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 Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 284002
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2020
• 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