MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MOTOR LEGEND EHS STYLUS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number EM200

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Report confirmed.The device was tested and the temperature rise of the motor was measured to be 65.1°f.In addition, the rate of temperature rise was above threshold at 6.6°f/sec at the mid-motor location.Initial diagnosis indicated that the rear motor bearing was worn.Due to the rate of temperature rise the device was also evaluated by engineering.All of the three stator winding resistances were out of specification value which resulted in a fail condition.The motor housing to winding resistances were within specification.During a brief no load test the motor vibrated, was noisy, and was not able to rotate freely.The motor rear bearing was shattered into fragments.The cause of the mid-motor overheating was from the required additional supply current due to the elevated frictional load condition from the rear bearing debris lodged between the rotor and stator.Only the motor¿s rear bearing outer race was visible within the bearing retainer.Gouging of the rotor was attributed to the rear bearing debris lodged between the rotor and stator.The motor¿s front bearing and collet¿s front bearing ran smoothly when manually rotated.The collet¿s rear bearing was gravelly and lubricant deficient when manually rotated.The observed overheating of the front motor bearing was attributed to the rear collet bearing elevated friction.The likely cause of these types of failures is due to inadequate preventative maintenance.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.Device has been in use for approximately 91 months with no record of factory service during this period.We will continue to monitor this complaint type for trends.

Event Description

Repair request initiated for device with the report of error message received when the motor was plugged into the console.It was reported that there was no patient impact.Repair escalated to product event on evaluation due to overheating over threshold.On follow up it was reported the error message was received during a procedure.It was confirmed there was no impact to the patient.Attempts to gather additional procedure or patient information were unsuccessful.Only the initial reporter's first name was known.

• Brand Name: MOTOR LEGEND EHS STYLUS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: david leers ; 4620 north beach street; ft. worth, TX 76137-3291 ; 8177886587
• MDR Report Key: 5735182
• MDR Text Key: 47711381
• Report Number: 1625507-2016-00022
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EM200
• Device Catalogue Number: EM200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2008
• 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