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

Model Number 283512

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 motor was corroded and runs not constantly. Further, the cable and tissue seal were found to be damaged and the resistance values of the keypad were out of range. The motor, motor cable and the hand control set 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. The corroded motor has a tendency to stick and not turn, hence is responsible for the issue reported by the customer. Also the damage to the tissue seal and motor cable may have been a result of user mishandling of the device, however, given the information provided, we cannot determine a definitive root cause for the same, along with that of the hand control set. A manufacturing record evaluation was performed for the finished device (serial number : 1851m4024r), 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 affiliate via phone, the micro tornado hp w handcontrol. Doesn¿t turn jammed motor. The arthroscopy procedure was completed with a replacement. No delay. No patient consequences. The device is available to be returned for evaluation.

• 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: 10662836
• MDR Text Key: 210986049
• Report Number: 1221934-2020-02953
• Device Sequence Number: 1
• Product Code: HRX
• 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

• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage