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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the unit was defective.Per service manual operational and diagnostic, the reported failure was confirmed.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 5/30/2018 and passed all functional testing before being returned to the customer.During evaluation, a short circuit was found at the motor cable and it was replaced.A preventive o-rings replacement was performed.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The possible root cause for the reported failure was thus identified as electrical failure at motor's cable.At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history lot: 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 5/30/2018 and passed all functional testing before being returned to the customer.

Event Description

It was reported by the affiliate in (b)(6) that during an unknown procedure, it was observed that the micro tornado hp w hand control device had an unspecified malfunction.During in-house engineering evaluation, it was determined that there was a short circuit at the motor cable on the device.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch 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 ; 6013142063
• MDR Report Key: 9520789
• MDR Text Key: 205993428
• Report Number: 1221934-2019-60138
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 12/26/2019
• 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