MAUDE Adverse Event Report: DEPUY MITEK HAND PC TORNADO SHAVER; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Catalog Number 288022

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The defect reported by the customer has been verified and repaired.On inspecting the device, further deficiencies were found to be impairing device function.The measures used for repairing the defects are listed in the "proof of repair".Mechanical upgrade performed, motor defective: replaced, defective motor cable replaced, defective o-rings replaced, unit cleaned, functional test performed, functional test acc.To test procedure completed, safety test checklist enclosed, hipot test completed, electrical safety test completed.A review into the depuy synthes mitek complaints system revealed four other complaints for this device's serial number.At this point in time, no corrective or preventative actions are required as the device has been repaired.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

One 288022 fms tornado handpiece, reported to elsg check unit, if necessary repair.Repair of unit.Unit is defect.Description of failure: don´t work suction.Device error message: no other information available, when was the problem discovered?: pre-operatively, surgical delay?: none.

• Brand Name: HAND PC TORNADO SHAVER
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): KIMBALL ELECTRONICS; poznanska 1c, tarnowo; pozan 02767 ; PL 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7213034
• MDR Text Key: 98292039
• Report Number: 1221934-2018-10021
• Device Sequence Number: 1
• Product Code: HRX
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 288022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2017
• Date Manufacturer Received: 03/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1