MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS HAND CONTROL INTERFACE - POWER/POWER MAX 115V; FLUID MANAGEMENT SYSTEM

Catalog Number 282003

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

The sales rep reported that during a shoulder repair, the customer's hand control interface cable started sparking.The sales rep reported that the device was turned off immediately and the pump and interface were replaced with another pump and interface.The sales rep reported that the device was sparking where the power cord plugs into the interface.The surgeon completed the procedure with no patient consequences or delays.The sales rep could not provide a lot number or age of the complaint device, but reported that the device has seen heavy use.The sales rep is reporting the pump as a complaint device to the ees biomed dept.The sales rep was not present at the case, no further information was available.Upon preliminary analysis of the returned device, excess saline residue was noted on the interface where the power cord is plugged in indicating, the device was possibly in a wet environment during surgery causing sparking.Due to the possibility that this failure could lead to patient/ user shock, this complaint is deemed reportable due to user error.A review of the initial complaint event description was performed by mitek medical affairs who determined on (b)(4) 2014 that the event was not reportable based on the information received at that time, and a further review would take place once the complaint device was returned to mitek for evaluation.The device was returned to mitek and after a preliminary analysis, mitek medical affairs made the decision on (b)(4) 2014 that this complaint event is a malfunction reportable event.

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.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation indicates excess saline residue on the interface where the power cord plugs in indicating the device was in a wet environment during procedure.The device was connected to a dyonics power console and a power max elite hand piece and when operated, it works as intended in forward, reverse and oscillate modes.No sparks were noted.Due to the presence of saline residue on the interface, it is possible the device was in a wet environment and therefore caused sparks when operated.This failure can be attributed to user error.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.At this point in time, no corrective action is required and 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

The sales rep reported that during a shoulder repair, the customer's hand control interface cable started sparking.The sales rep reported that the device was turned off immediately and the pump and interface were replaced with another pump and interface.The sales rep reported that the device was sparking where the power cord plugs into the interface.The surgeon completed the procedure with no patient consequences or delays.The sales rep could not provide a lot number or age of the complaint device, but reported that the device has seen heavy use.The sales rep is reporting the pump as a complaint device to the ees biomed dept.The sales rep was not present at the case, no further information was available.Upon preliminary analysis of the returned device, excess saline residue was noted on the interface where the power cord is plugged in indicating, the device was possibly in a wet environment during surgery causing sparking.Due to the possibility that this failure could lead to patient/ user shock, this complaint is deemed reportable due to user error.A review of the initial complaint event description was performed by mitek medical affairs who determined on 02/06/2014 that the event was not reportable based on the information received at that time, and a further review would take place once the complaint device was returned to mitek for evaluation.The device was returned to mitek and after a preliminary analysis, mitek medical affairs made the decision on 04/01/2014 that this complaint event is a malfunction reportable event.See associated medwatch # 1221934-2014-00138.

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 process.

Event Description

The sales rep reported that during a shoulder repair, the customer's hand control interface cable started sparking.The sales rep reported that the device was turned off immediately and the pump and interface were replaced with another pump and interface.The sales rep reported that the device was sparking where the power cord plugs into the interface.The surgeon completed the procedure with no patient consequences or delays.The sales rep could not provide a lot number or age of the complaint device, but reported that the device has seen heavy use.The sales rep is reporting the pump as a complaint device to the ees biomed dept.The sales rep was not present at the case, no further information was available.Upon preliminary analysis of the returned device, excess saline residue was noted on the interface where the power cord is plugged in indicating, the device was possibly in a wet environment during surgery causing sparking.Due to the possibility that this failure could lead to patient/ user shock, this complaint is deemed reportable due to user error.A review of the initial complaint event description was performed by mitek medical affairs who determined on (b)(4) 2014 that the event was not reportable based on the information received at that time, and a further review would take place once the complaint device was returned to mitek for evaluation.The device was returned to mitek and after a preliminary analysis, mitek medical affairs made the decision on (b)(4) 2014 that this complaint event is a malfunction reportable event.See associated medwatch # 1221934-2014-00138.

• Brand Name: MITEK FMS HAND CONTROL INTERFACE - POWER/POWER MAX 115V
• Type of Device: FLUID MANAGEMENT SYSTEM
• 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: 3718826
• MDR Text Key: 17986879
• Report Number: 1221934-2014-00112
• 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,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 282003
• Device Lot Number: 10057201
• 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: 01/24/2014
• Event Location: Ambulatory Surgical Center
• Date Report to Manufacturer: 01/24/2014
• Date Manufacturer Received: 01/24/2014
• 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