MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS TORNADO SHAVER HANDPIECE; ARTHROSCOPIC SHAVER

Catalog Number 288022

Device Problems Unknown (for use when the device problem is not known) (2204); Device Operates Differently Than Expected (2913)

Patient Problems Surgery, prolonged (2177); No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2015

Event Type  Injury  

Event Description

The following information was received from the call center report on (b)(6) 2015 and summarized by a mitek complaint analyst; the customer is complaining about: when the tornado shaver was plugged in the system switched off.The physician didn¿t have another tornado shaver.The surgeon completed the procedure without the fms tornado shaver or any depuy synthes mitek equipment, causing a delay longer than 30 minutes.The patient was not adversely affected and is reported to be fine.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.

Manufacturer Narrative

The complaint device was received and evaluated.Visual and functional testing revealed no anomies and the unit passed all tests with acceptable results.Further a review into the depuy synthes mitek complaints system revealed no other complaints for this device's serial number.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.

Event Description

The following information was received from the call center report on 5-28-15 and summarized by a mitek complaint analyst; the customer is complaining about: when the tornado shaver was plugged in the system switched off.The physician didn't have another tornado shaver.The surgeon completed the procedure without the fms tornado shaver or any depuy synthes mitek equipment, causing a delay longer than 30 minutes.The patient was not adversely affected and is reported to be fine.

• Brand Name: MITEK FMS TORNADO SHAVER HANDPIECE
• Type of Device: ARTHROSCOPIC SHAVER
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4869450
• MDR Text Key: 6042543
• Report Number: 1221934-2015-00843
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 288022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2015
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention