MAUDE Adverse Event Report: DEPUY MITEK MITEK FLUID MANAGEMENT SYSTEM INTERFACE CABLE; FMS EQUIPMENT SYSTEMS

Catalog Number 282003

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, delayed (2565)

Event Date 02/04/2014

Event Type  Injury  

Event Description

Our sales rep reported that during setup for a shoulder procedure the fms interface cable would not completely plug into the shaver, preventing the shaver and pump from being used in the procedure.The customer switched to a competitor's pump and accessories for the procedure.There was an approximate 40 minute delay in the procedure due to the changeover of equipment, with the patient under anesthesia during the extended time.The procedure was completed successfully with no reported adverse patient consequences to the patient.The sales rep stated that the complaint device was at least five years old, it is being returned to mitek for evaluation.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy 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 observation indicated that the connector was completely crushed and could not be plugged into the console.The device was worn and the lot number was not fully legible and therefore the age of the device could not be determined.But visual appearance of the device indicates the device had been heavily used in the field.The damage to the connector indicates it was mishandled and therefore this complaint can be confirmed and the failure can be attributed to field wear due to rough handling.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point, no further action is warranted.However, depuy 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

Our sales rep reported that during setup for a shoulder procedure the fms interface cable would not completely plug into the shaver, preventing the shaver and pump from being used in the procedure.The customer switched to a competitors pump and accessories for the procedure.There was an approximate 40 minute delay in the procedure due to the changeover of equipment, with the patient under anesthesia during the extended time.The procedure was completed successfully with no reported adverse patient consequences to the patient.The sales rep stated that the complaint device was at least five years old, it is being returned to mitek for evaluation.

• Brand Name: MITEK FLUID MANAGEMENT SYSTEM INTERFACE CABLE
• 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: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3640021
• MDR Text Key: 4181519
• Report Number: 1221934-2014-00075
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 282003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/04/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2014
• Date Manufacturer Received: 02/05/2014
• 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