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

Catalog Number 283512

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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, we were able to only partially verify the defect(s) reported by the customer.On inspecting the device, further deficiencies were found to be impairing device function.The following repair activities were performed: unit modified acc.To guideline of manufacturer.Unit safety test performed.Functional test performed.Electrical safety test completed.Hipot test completed.Functional test completed.Defective o-rings replaced.Bend protection damaged - motor cable replaced."micro": preventive replacement of o-rings performed acc.To service manual.The root cause of the reported failure is undetermined.However, deficiencies found to be impairing the functionality of the device were found to be damaged insulation cable, defective o-ring, and burr not being able to fit.The defects were replaced and the device was restored to specification and functions as intended.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.(b)(4).

Event Description

It was reported by the affiliate that post operatively the micro tornado hand piece with hand control didn't hold burrs and needs service.The case was completed by using a replacement device without any patient harm or surgical delay.

• 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: 8369566
• MDR Text Key: 137127805
• Report Number: 1221934-2019-56487
• 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: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2019

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: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1