MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MIDAS REX® MOTOR LEGEND EHS STYLUS REFURB; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	EM200-R
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.The device was tested and the rate of temperature rise was measured to be 76.7°f.The rate of temperature rise was above threshold at 6.4°f/second at the mid-motor.Initial diagnosis also indicated multiple bearings were worn and the shaft was cracked.Engineering evaluation determined the motor rear bearing was shattered into fragments.Only the motor¿s rear bearing outer race was visible within the bearing retainer.The rotor was scored, which would be attributed to the rear bearing debris.The mid-motor overheating was caused by the additional supply current required to maintain motor speed due to the elevated frictional load condition, which was caused by rear bearing debris lodged between the rotor and the stator.These findings were likely due to inadequate preventative maintenance.This type of failure is associated with (b)(4).Multiple warnings are included in the ipc user manual including: heavy side loads and/or long operating periods may cause the device to overheat.Do not use an overheated device, as it may cause thermal injury to the patient or operator.Use adequate irrigation.The use of tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue.Depending on the amount of irrigation used the drill bits and saw blades can achieve temperatures in excess of 50°c.Do not attempt to change a dissecting tool, saw blade, or attachment while the motor is running, or when the motor or attachment is in an overheated state.Smoke and/or excessive heat may be generated if attachment is not in the fully locked position.This may result in thermal injury to the surgeon or staff.The preventive maintenance/ service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.This device has been in use for approximately 25 months with no record of factory service during this period.We will continue to track and trend this complaint type.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Repair request initiated for device with the report of overheating.It was reported that there was no patient or staff impact.Repair request escalated to a product event due to overheating over threshold.On follow up it was reported the event occurred during an ent procedure and no additional non-routine actions were taken due to the overheating.A back up device was used with no delay in the procedure.It was confirmed there was no impact.No additional information regarding the patient or attachment used with the motor was provided.Initial reporter information was provided as well as event date.

• Brand Name: MIDAS REX® MOTOR LEGEND EHS STYLUS REFURB
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6561670
• Report Number: 1045254-2017-00147
• Device Sequence Number: 19028008
• Product Code: HBE
• UDI-Device Identifier: 00613994422002
• UDI-Public: 00613994422002
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K012457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EM200-R
• Device Catalogue Number: EM200-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1