MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS DUO + PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS

Catalog Number 284580

Device Problems Unknown (for use when the device problem is not known) (2204); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unknown (for use when the patient's condition is not known) (2202); No Information (3190)

Event Date 06/18/2015

Event Type  Injury  

Event Description

The pump per intermittence stopped to work.The surgeon tested another shaver and issue persisted.No adverse patient consequence reported, patient is fine.The following additional information was received via email from the international call center on 06-23-15; "in fact the customer explained that the physician decide to stop the procedure as the issue was due to the pump and when customer called me the order wasn¿t renewed.".

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.

Manufacturer Narrative

Unit passed all tests, test report on file.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 pump per intermittence stopped to work.The surgeon tested another shaver and issue persisted.No adverse patient consequence reported, patient is fine.The following additional information was received via email from the international call center on (b)(4)-2015; "in fact the customer explained that the physician decide to stop the procedure as the issue was due to the pump and when customer called me the order wasn't renewed".

• Brand Name: MITEK FMS DUO + PUMP/SHAVER COMBO
• Type of Device: FMS EQUIPMENT SYSTEMS
• 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: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4949600
• MDR Text Key: 18893028
• Report Number: 1221934-2015-00887
• 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,company represent
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/18/2015
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2015
• Date Manufacturer Received: 06/18/2015
• 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