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

Model Number 283512

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the customer via email, shaver switches from oscillating to bur handpiece to footpiece footpiece not attached another handpiece worked fine no adverse reaction to paitent or case delay.

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.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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: additional information was requested, and the following was obtained: *what was the procedure in which the device was involved? either a shoulder arthroscopy or knee arthroscopy.Sorry, it was a couple of weeks ago.Not sure which.Correction: b4: upon complaint review, it was determined that the exact date of the event was unknown; however, it was noted to have occurred on (b)(6) 2020.B5: upon complaint review, it was determined that the event description was incorrectly transcribed.Therefore, the b5 has been updated as follows: it was reported that during an unknown arthroscopy procedure on an unknown date, it was observed that the micro tornado hp w handcontrol device switched from oscillating in handpiece to foot piece while it was not attached.Another handpiece device was used to complete the surgery successfully without delay.There were no adverse patient consequences reported.All available information has been disclosed.If additional information becomes available, a supplemental medwatch will be submitted accordingly.E1: the user facility's address was inadvertently missed on the initial report and has been updated accordingly.

Event Description

It was reported that during an unknown arthroscopy procedure on an unknown date, it was observed that the micro tornado hp w handcontrol device switched from oscillating in handpiece to foot piece while it was not attached.Another handpiece device was used to complete the surgery successfully without delay.There were no adverse patient consequences reported.All available information has been disclosed.If additional information becomes available, a supplemental medwatch will be submitted accordingly.

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.Investigation summary: the device was received and evaluated at the service center.The reported complaint regarding the unintended motion of the device could be confirmed.It was found that the buttons, cable and the motor of the device were defective.The defective parts were replaced, a preventive maintenance was performed, and the device was tested and found to be working according to specifications.Given the information provided, we cannot discern a definitive root cause of the identified failures.The defective components of the device would have caused the device to not function as intended as reported by the customer.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 03/16/2020 and passed all functional testing before being returned to the customer.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: 10590911
• MDR Text Key: 208713483
• Report Number: 1221934-2020-02769
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2020
• 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: 09/29/2020
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1