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

Catalog Number 284002

Device Problem Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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).The device was received at the service center and evaluated. per service manual operational and diagnostic analysis confirmed reported issue (not maintaining pressure ).Replaced springs on pressure arms with tip replacement kit as identified in the investigation to address the reported issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.Per sb, performed software upgrade to 3.11 and performed cpld version upgraded to 1.7 (see form in attachments).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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the sales rep that the fms vue pump was not maintaining pressure consistently.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device was available for use.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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: 9036514
• MDR Text Key: 191001668
• Report Number: 1221934-2019-58303
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 09/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1