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 Not Applicable (3189)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: the device was sent to the service center for repair.The repair report indicates: motor does not turn: motor replaced.Defective drill mounting mechanism 1.0 has been replaced by 1.25 (this is performed to upgrade the hand pieces) short circuit in the motor cable - motor cable replaced.Resistance value out of specs: handcontrol set replaced."micro": preventive replacement of o-rings performed acc.To service manual the defective motor and the short in the motor cable are the root causes of this failure.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device serial number on 4-23-2019, and no non-conformances were identified.At this point in time, 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) via phone that during an unspecified surgical procedure, it was observed that the micro tornado handpiece with hand controls would not work once plugged in.There was a five minute delay in the surgery to open another device.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.During in-house engineering evaluation, it was determined that there was a short circuit in the motor cable on the device.All available information has been disclosed.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: 8582141
• MDR Text Key: 144803885
• Report Number: 1221934-2019-57017
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/21/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/06/2019
• 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