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 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the affiliate in (b)(6) that the motor on the micro tornado hp w handcontrol device was not working; that there was no function. During in-house engineering evaluation, it was determined that there was a short circuit in the motor cable on the device. There was no procedure nor patient involvement 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: 12385914
• MDR Text Key: 268738055
• Report Number: 1221934-2021-02575
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/30/2021
• 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: 08/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A