MAUDE Adverse Event Report: DEPUY MITEK LLC US 8022 HANDPC TORNADO SHAVER; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 288022

Device Problem Corroded (1131)

Patient Problem Not Applicable (3189)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device stopped during the surgery and it didn¿t work was confirmed.It was found that the motor sticks and was rusty and also that the cable did not pass the cable screening test.The defective motor was replaced along with the motor cable and the device was repaired, tested and found to be fully functional.Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor and would have damaged the motor cable.The corroded motor has a tendency to stick and not turn, hence is responsible for the issue reported by the customer.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 10/16/2019 and passed all functional testing before being returned to the customer.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.Initial reporter phone number: (b)(6).Udi:(b)(4).

Event Description

It was reported by affiliate via mail the 8022 handpc tornado shaver.This device stopped during the surgery and it didn¿t work.The procedure was completed with another device.The surgery had a delay of 20 minutes.The device is available to be returned for evaluation.

• Brand Name: 8022 HANDPC TORNADO SHAVER
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10652124
• MDR Text Key: 210988308
• Report Number: 1221934-2020-02919
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2020

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: 288022
• Device Catalogue Number: 288022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1