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

Catalog Number 284002

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device was sent to the service center for evaluation.Per service manual operational and diagnostic analysis confirmed reported issue (the out-flow stopped working).Removed foreign debris from suction's follower arm assembly 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.A check of the manufacturing finished goods records for the reported serial number went under review.These serialized devices were released for distribution on june 18, 2014 expiration date not applicable.There were no anomalies or discrepancies in the manufacture of this lot.Furthermore, a review of the depuy synthes mitek complaints system revealed one similar and six dissimilar complaints for this serialized device.And at this 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.Udi: (b)(4).

Event Description

The 284002 fms vue pump.Rotator cuff.No patient harm.Less then 15 minute delay.Used another fms vue.Dr.Was using the in-flow / out-flow for the procedure, the out-flow stopped working.Additional information from the sales rep 8-22-2018: was the procedure able to be completed? yes.Were alternatives readily available? yes.Was there any excessive pressure? yes this is why we stopped using it.Was there any excessive swelling or extravasation? no.Also, if there was extravasation what it is the patient's current status? healthy and safe.

• 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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7806758
• MDR Text Key: 118111389
• Report Number: 1221934-2018-54528
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• 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: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1