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

Model Number 283512

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4). The device was received and evaluated at the service center. The reported complaint that the set rotation speed of the hand piece and the actual rotation speed do not match was confirmed. It was found that the resistance values of the keypad were out of range and that the keypad was not responding properly. Further, the motor was stuck and the protective earth resistance of the motor cable was out of range. The motor, the 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 device is one possible root cause of the damage to the motor. However, given the information provided, we cannot discern a definitive root cause of the other defective parts. The defective components of the device would have caused the device to not function as intended as reported 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.

Event Description

It was reported by the affiliate in (b)(6) that the set rotation speed and the actual rotation speed did not match on the micro tornado hp w handcontrol device. During in-house engineering evaluation, it was determined that the resistance values of the keypad were out of range and that the keypad was not responding properly. Furthermore, the motor was stuck and the protective earth resistance of the motor cable was out of range. There was no procedure involved reported. There were no adverse patient consequences reported. No additional information was provided.

• 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 LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11081354
• MDR Text Key: 224404972
• Report Number: 1221934-2020-04015
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2020
• 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: 11/06/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A