MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS DUO+PUMP/SHAVER UNIT; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284580

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the customer in (b)(6) that during an unknown procedure on (b)(6) 2020, it was observed that the pump/shaver device doesn't work properly that it has an issued with the pump flow.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: investigation summary
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> the complaint device was received at the service center and evaluated.It was reported that the device does not work properly.There was an issue with the pump flow.Per service reports, this complaint can be confirmed.It was found during evaluation that the left and right lexan covers were broken.Further, tips and rubber feet were worn out.Also found that chamber holder and guideline were twisted.The maintenance kit and safety cover were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.User mishandling or a probable fall might be the most probable root cause for the broken lexan covers and for the twisted chamber holder and guideline.Due to prolonged usage overtime tips and rubber feet might worn out.This device was produced prior to the closure of the fms facility in nice, france and therefore will not have a dhr review preformed.Please see signed legacy fms batch review.At this point in time, no corrective action is required, and no further action is warranted.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.H11 correction narrative: d4: the udi was inadvertently missed on the initial report; and has been updated accordingly.

• Brand Name: FMS DUO+PUMP/SHAVER UNIT
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11100838
• MDR Text Key: 224825096
• Report Number: 1221934-2020-04169
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/01/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1