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 No Consequences Or Impact To Patient (2199)

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 doesn't turn due to a jammed motor was confirmed.It was found that the the motor sticks and was rusty.Further, the cable resistance was out of tolerance.The motor and the motor cable were replaced 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 could have caused the damage to 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 07/05/2019 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.Udi: (b)(4).

Event Description

It was reported by the affiliate via a service request that the 8022 handpc tornado shaver did not turn due to a possible jammed motor.The event occurred intra-operatively and there was no impact on the patient.It was reported the procedure was completed with a replacement device and there was no known surgical delay.

• 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: 10662340
• MDR Text Key: 210987993
• Report Number: 1221934-2020-02951
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2020

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: 09/24/2020
• Initial Date FDA Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1