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

Model Number 283512

Device Problem Electrical Shorting (2926)

Patient Problem Not Applicable (3189)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device did not function was confirmed.During initial evaluation, it was found that the handpiece was difficult to be connected and disconnected and also presented activation issues.It was further found that the resistance value of the keypad of the handcontrol set was out of specifications and an o-ring was found to be missing.The handcontrol set and the missing o-ring was replaced and the device was cleaned, tested and found to be fully functional.It is possible that the o-ring went missing during the cleaning process by the customer.However, given the information provided we cannot discern a definitive root cause for the same, along with the defective keypad of the handcontrol set and that for the connection issues.The defective handcontrol set would have caused the device to not function as intended by the customer.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.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.Udi: (b)(4).

Event Description

It was reported by the sales rep via personal interaction that during an arthroscopic meniscectomy procedure when the surgeon pressed the button on the shaver, the micro tornado hp w handcontrol did not work with the beep.Replacing the shaver blade did not solve the issue.The surgery was completed less than a 30-minute surgical delay.There was no harm to the patient.The device was brand new and the first use when the issue occurred.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9782127
• MDR Text Key: 204779332
• Report Number: 1221934-2020-00736
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2020

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: 01/30/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1