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 Not Applicable (3189)

Event Date 01/13/2019

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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a shoulder procedure the outflow of the fms vue pump was not working.The procedure was completed in solo mode with no patient harm but there was a 10 minute surgical delay.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device was received and evaluated at the service and repair center.Per service manual, operational and diagnostic analysis does not confirm the reported issue (outflow not working).Hence, this complaint cannot be confirmed nor can we determine a definite root cause for the reported failure.However, another deficiency was found to be impairing the functionality of the device.The pinch valve guard is damaged, this could have led the customer to experience the device not to function as intended.However, the repair and testing of the unit will not be completed at this time because there is no need for it in the pool due to excess units in the pool at this time.A manufacturing record evaluation was performed for the finished device serial number (e43a20745), and no non-conformances 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.Udi:(b)(4).

• 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
• MDR Report Key: 8499641
• MDR Text Key: 141468449
• Report Number: 1221934-2019-56802
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• Combination Product (y/n): N
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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: 04/03/2019
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/13/2019
• Patient Sequence Number: 1