MAUDE Adverse Event Report: DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284590

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the defect reported could not be verified.The following service activities were performed: performed service and repair functions.Reviewed service history.Attach box label and electrical safety.The unit was evaluated and the reason for return: "pump kept spinning and would not flush" could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.Details can be found in the attached reports.Further a review into the depuy synthes mitek complaints system revealed no other complaints for this device's serial number.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 from the (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported the customer¿s fms solo pump kept spinning and would not flush during an unknown surgery.Reportedly there was no patient harm; there was a two (2) minute surgical delay to switch out the pump.

• Brand Name: 4590 FMS SOLO IRRIGATION PUMP -NS
• 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: 8020724
• MDR Text Key: 125603345
• Report Number: 1221934-2018-51243
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020614
• UDI-Public: 10886705020614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002040
• 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: 02/09/2016

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: 284590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 10/30/2018
• 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: Reuse
• Patient Sequence Number: 1