MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283512

Device Problem Infusion or Flow Problem (2964)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event.It was reported by sales rep that during an arthroscopy on an unknown date, it was observed that the suction on two fms tornado micro handpiece with buttons could not be activated.Both handpieces failed to respond to the suction deactivation when toggled to that position.Devices were replaced to complete procedure with a delay of 10 minutes.No 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.Correction: d4: upon complaint review, it was determined that the serial number has been updated to reflect the correct information.Therefore, udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.Per service manual operational and diagnostic, no defect was found with the device; therefore, this complaint cannot be confirmed.Preventive maintenance was carried out and the device was found to be fully functional.As the reported problem was not confirmed, a root cause for the issue that was experienced by the user cannot be determined.Since no failure was identified with the device, a manufacturing record evaluation is not required.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.

• Brand Name: MICRO TORNADO HP W HANDCONTROL
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10343554
• MDR Text Key: 202225208
• Report Number: 1221934-2020-01960
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• 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: 07/15/2020

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 Model Number: 283512
• Device Catalogue Number: 283512
• Device Lot Number: 1708M2642R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/05/2020
• Patient Sequence Number: 1