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

Catalog Number 283512

Device Problem Electrical Shorting (2926)

Patient Problem Not Applicable (3189)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.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.The sales rep reported an issue of the device was overheated.Per operational and diagnostic, this complaint can be confirmed.During evaluation, it was found that the device was overheated due to a seized motor.Additionally, the cable was causing the device to display short errors, the keypad was not functioning due to corrosion, the button cover and valve handles heavily scratched.Performed repair as identified in the investigation to address the reported issue by replacing the motor, cable, keypad pcb, screws & button cover, and micro valve set.The unit passed all functional tests and is fully operational.Per repair analysis, the handpiece was found to be physically damaged.The seized motor is identified as the root cause of the reported problem of the device was overheated.Fluid ingress into the keypad might have caused corrosion of the keypad.User mishandling is the possible root cause for the observed scratches on the button cover and valve handles.With the given information, we cannot determine the root cause of the defective cable or damaged handpiece.A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances were identified.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.Udi:(b)(4).

Event Description

As per the sales rep via phone, the micro tornado handpiece overheated.They were able to complete the case with another like device.This did cause a 3 minute delay but caused no patient harm.This is all the information the sales rep has at this time.

• 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
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9167865
• MDR Text Key: 208387264
• Report Number: 1221934-2019-58853
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1