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

Catalog Number 283512

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the device was sent to the service center for repair.The defect reported by the customer has been verified and repaired.On inspecting the device, further deficiencies were found to be impairing device function.   resistance value out of specs: hand control set replaced; short circuit in the motor cable - motor cable replaced; "micro": preventive replacement of o-rings performed; according to service manual; unit cleaned; functional test performed; hipot test completed; electrical safety test according completed; functional test according to test procedure completed; safety test checklist enclosed.Further information regarding the cause of the defect has been provided in the input check report to help determine a root cause for this failure.When there is a short circuit in the motor cable, the motor may not run smoothly therefore is a potential root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, no corrective action is required and no further action is warranted.However, depuy synthes 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 post-operatively to an unknown procedure, it was observed that the micro tornado handpiece with handcontrols device would not turn as the motor was jammed.During in-house engineering evaluation, it was determined that there was a short circuit in the motor cable on the device.It was not reported if there was a delay in the surgical procedure but a replacement device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.The exact date of the event was unknown but was noted to have occurred in 2018.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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 ; 6103142063
• MDR Report Key: 8173484
• MDR Text Key: 131157076
• Report Number: 1221934-2018-55704
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 12/17/2018
• Date Device Manufactured: 12/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1