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

Model Number 283512

Device Problem Fitting Problem (2183)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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.

Event Description

It was reported that shaver blades couldn't be fixated in the shaver.There were no patient consequences.Changed to competitive shaver to complete the procedure and there was 5 minute delay.

Manufacturer Narrative

(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.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.The device was sent to service center for service and repair.The defect reported by the customer has been verified and repaired.Following repair activities were performed on the device: preventive replacement of o-rings performed according to service manual, resistance value out of specifactionss: handcontrol set replaced, defective o-rings replaced, unit cleaned, functional test performed, hipot test completed, electrical safety test completed, functional test completed, safety test checklist enclosed.A device history record (dhr) review has been conducted and the results indicate that this batch of the handpiece handle body was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.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).

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.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.Udi: (b)(4).

• Brand Name: MICRO TORNADO HP W HANDCONTROL
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7262505
• MDR Text Key: 100128287
• Report Number: 1221934-2018-50161
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: (01)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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2018
• 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: 02/09/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1