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

Model Number 283512

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the suction lever was stuck and that the feature would not turn on, was confirmed. It was further found that the cable, motor and the button of the device were defective. The handpiece was also found to be physically damaged. The defective parts were replaced and the device was tested and found to be working according to specifications. The physical damage to the handpiece is most likely a result of user mishandling of the device, possibly during transportation or storage. The damaged components of the handpiece would have caused it to not function as intended 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. Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a shoulder repair procedure the customer's micro tornado handpiece with hand controls suction lever was stuck and that feature would not turn on. The case was completed with another like-device with no patient harm or delay. The device is being returned.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9789128
• MDR Text Key: 205929090
• Report Number: 1221934-2020-00755
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/04/2020
• 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: 02/10/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/20/2020
• 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