MAUDE Adverse Event Report: DEPUY MITEK FMS DUO PLUS PUMP & SHAVER COMBO; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284580

Device Problem Pressure Problem (3012)

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.The defect reported could not be verified but a different defect was identified.This pump is 10 years old and has possibly seen heavy use in the field.The root cause for the reported failure mode cannot be discerned.The following repair activities were conducted: mechanical upgrade performed; unit cleaned; defective material exchanged; 8-hour endurance test carried out; unit calibrated newly; pneumatic circuit checked; functional test performed; hipot test completed; electrical safety test acc.To iec 60601-1 completed; functional test acc.To test procedure completed; safety test checklist enclosed.Further, a review into the depuy mitek complaints system revealed one similar and one dissimilar complaint for this device's serial number.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.(b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the affiliate in (b)(6) that during pre-surgery, it was observed that the pressure was too high on the device.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement.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: FMS DUO PLUS PUMP & SHAVER COMBO
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7723157
• MDR Text Key: 115593093
• Report Number: 1221934-2018-52640
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020607
• UDI-Public: 10886705020607
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2014

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: 284580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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