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 No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the device was received and evaluated at the service center. The reported complaint that the left arm of the device was malfunctioning, was confirmed. It was found that the seal was missing and that the left follower arm is stuck. Also the tips of the arm were found to be worn. The irreparable pressure mechanism was replaced, the defective material exchanged, and the device was cleaned, newly calibrated, tested and found to be fully functional. The worn tips are a result of prolonged usage of the device over time. The missing seal can be attributed to user mishandling of the pump. However, given the information provided, we cannot determine a definitive root cause for the stuck follower arm. A manufacturing record evaluation was performed 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. Depuy 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. Udi: (b)(4).

Event Description

Service: who was involved? patient? no impact on the patient. When? intraoperatively. What happened? malfunctioning left arm. What device(s)? one device fms vue. The outcome of the event? the procedure has been completed. No surgical delay. How was the surgery ended? the used replacement device.

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10617577
• MDR Text Key: 209849439
• Report Number: 1221934-2020-02830
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/01/2020
• 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: 09/07/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage