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

Model Number 288022

Device Problems Corroded (1131); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the cable of the device was damaged.Per service reports, this complaint can be confirmed.It was found during evaluation that the protective conductor resistance of the motor cable was out of tolerance.Further, the motor was stuck and rusty.It was also noticed that the blade did not lock into the shaver, and the drill mounting mechanism was defective and its parts were damaged.Moreover, the o-rings were found to be defective.The motor, motor cable, o-rings and the damaged parts of the drill mounting mechanism were replaced to resolve the issues.The device was cleaned, tested and found to be fully functional.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.Corroded motor has a tendency to stick and not turn.The defective o-rings might have caused the blade not to lock into the shaver.With the available information, we cannot determine the root cause of the other identified failures.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 01/31/2019 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.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

The cable of the tornado shaver damaged.S/n: (b)(4).

• 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: 10621641
• MDR Text Key: 209638788
• Report Number: 1221934-2020-02847
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1