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

Catalog Number 284580

Device Problem Unintended Movement (3026)

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

Event Date 12/31/2020

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 sales rep that during a knee arthroscopy procedure on (b)(4) 2020, it was observed that the fms duo®+pump/shaver unit device was cycling faster than normal.The procedure was completed with the same device without delay.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.Investigation summary : the device was received and evaluated at the service center.The reported complaint that the pump was cycling faster than normal, was unable to be confirmed.No defects were found with the pump upon evaluation.The device was tested and found to be working according to specifications.The device was however placed into long-term hold as it was not needed for the equipment exchange pool use.Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined.No manufacturing record evaluation is required as no manufacturer or service related issues were found with the device.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.

• 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: 11201930
• MDR Text Key: 227790932
• Report Number: 1221934-2021-00160
• 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
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: 01/04/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1