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

Model Number 283512

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.Initial reporter phone number: (b)(6).Udi: (b)(4).

Event Description

It was reported by the customer as following: the gasket of the device came off after an unknown procedure.No harm to the patient reported.No delay reported.No further information available.Loaner requested.

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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 complaint device was received at the service center and evaluated.It was reported that the gasket of the device came off.Per service reports, this complaint can be confirmed.It was found during evaluation that the motor was corroded.Further, valve, head screw and levers were damaged.Cable and keyboard were in good condition.The motor, maintenance kit, valve and levers were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.The damaged valve, head screw and levers is most likely caused by external factors like user mishandling or a probable fall.A manufacturing record evaluation was performed for the finished device serial/lot number ((b)(6)), and no non-conformance was identified.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: 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: 10623521
• MDR Text Key: 209820255
• Report Number: 1221934-2020-02868
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 12/11/2020; 02/25/2021
• Supplement Dates FDA Received: 12/14/2020; 02/26/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1