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

Catalog Number 283512

Device Problem Self-Activation or Keying (1557)

Patient Problem Not Applicable (3189)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).

Event Description

It was reported by the affiliate that the micro tornado handpiece with hand controls was not responding and was working automatically.A spare one has been used to complete the procedure.No patient consequences.There was a 15 to 20 mins of delay.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 complaint device was received and evaluated at the service and repair center.Per service report, the reported failure of the device not functioning as intended was verified.Hence, this complaint can be confirmed.During evaluation, the motor was found to be in good working order.However, the following deficiencies were identified to be impairing the functionality of the device: cable resistance value out of tolerance limits.Keyboard resistance value out of tolerance limits.When the resistance values of the keypad and cable are out of range the buttons of the device may not respond, therefore is a potential root cause which could impact the functionality of the device causing it not to function as intended and lead the customer to experience the reported failure.However, we cannot determine what caused the out of tolerance failure.The defective components were replaced and the device was restored to specification and is now fully functional.Furthermore, a manufacturing record evaluation was performed for the finished device serial number (1450m5244r), and no non-conformances related to the reported complaint condition were identified.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.Udi: (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Event description: subsequent follow-up with the customer, additional information was received.The reporter stated that the shaver didn't respond to the hand control or started automatically.

• 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: 8464804
• MDR Text Key: 140319030
• Report Number: 1221934-2019-56721
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• 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: 04/23/2019
• Date Manufacturer Received: 06/04/2019
• Patient Sequence Number: 1