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

Catalog Number 284590

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The device was received at the service center and repaired.The unit was evaluated and the reason for return (incorrect pressure) was verified.Replaced worn finger on complete pressure adjuster (preventive maintenance) with tip replacement kit to address (incorrect pressure.) the unit passed all diagnostic tests, functional tests, and is fully operational.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 to monitor the extent to 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 by the customer that during a shoulder arthroscopy surgical procedure, it was observed that the 4590 fms solo irrigation pump device was displaying incorrect pressure.According to the reporter, the pressure was either too high or too low.There was a delay in the surgical procedure of less than 15 minutes.An identical spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8269021
• MDR Text Key: 134457654
• Report Number: 1221934-2019-56089
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• 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: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Date Device Manufactured: 06/13/2007
• 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