MAUDE Adverse Event Report: DEPUY MITEK LLC US TORNADO MICRO HANDPIECE WITH BUTTONS; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283512

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was received and evaluated at the service center.The complaint reported by the customer that the device doesn't turn as the motor is jammed has been confirmed.It was found that the motor did not turn as the shaft was jammed.The insulation resistance of the motor cable was out of tolerance and there was a short circuit in the motor.The device failed the hipot test.The defective motor and the motor cable are the root causes of the reported issue from the customer.However, given the information provided we cannot discern a definitive root cause for the defective motor and motor cable.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 11/28/2018 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.A review of the device history record.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes mitek reports an event in (b)(6) as follows: it was reported by the affiliate that the micro tornado hand piece with hand control doesn't turn as the motor is jammed and needs service.There was patient involvement but no impact to the patient was reported.The case was identified post-op.The case was completed using a replacement device.There was no surgical delay reported.This report is 1 of 1 for (b)(4).

• Brand Name: TORNADO MICRO HANDPIECE WITH BUTTONS
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8962985
• MDR Text Key: 156921137
• Report Number: 1221934-2019-58198
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: (01)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: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2019

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 Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1