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

Model Number 283512

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that before a rotator cuff repair procedure the o-ring of the fms tornado micro handpiece with buttons popped out of the shaver.Another devices was used to complete the procedure.No patient consequences, or surgical delay reported.The device is available to be returned for evaluation.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary :he device was received and evaluated at the service center.The reported complaint that the o-ring of the fms tornado micro handpiece with buttons popped out of the shaver was confirmed.It was found that the device was physically damaged.Further, the motor, motor cable and the o-rings were found to be defective.There were also minor scratches on the device identified during decontamination.The defective parts were replaced and the device was tested and found to be working according to specifications.The physical damage to the device and the minor scratches are most likely a result of user mishandling of the device.However, given the information provided, we cannot discern a definitive root cause of the other identified failures.A manufacturing record evaluation was performed for the finished device [serial number : (b)(6), 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.

• 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
• MDR Report Key: 10715673
• MDR Text Key: 212475064
• Report Number: 1221934-2020-03146
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/04/2020
• Removal/Correction Number: N/A
• Patient Sequence Number: 1