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

Model Number EM100-A

Device Problems Overheating of Device (1437); Difficult To Position (1467)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Report confirmed.The device was tested and the temperature was measured to be 151.4°f and the rate of temperature rise was above threshold at 6.2°f/sec.Engineering evaluation was performed and it was determined a tool would not seat and lock in the motor.The motor ran for a few seconds before the ipc console aborted the run and displayed an error message.The collet was removed and the motor was tested without the collet.The motor ran smoothly without overheating.Upon disassembly of the collet, it was noted the collet spring was deformed.The appearance of the spring indicated elevated temperature sufficient to cause permanent deformation in both the free spring height and the outer diameter for several coils.The likely cause for the overheating condition was identified as operation of the motor with the collet in a partially or fully unlocked state.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.In addition, midas rex legend ehs motor and midas rex legend ehs stylus motor should only be operated when the attachment is in the locked position.We will continue to monitor this complaint type for trends.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 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 based on analysis finding of overheating above threshold.On follow up it was reported heating occurred within a minute and was noisy.The overheating was discovered prior to the start of the case.The facility did have a backup device to use with no delay in the procedure.No information on the attachment used with the motor was available.

• Brand Name: MIDAS REX® LEGEND EHS MOTOR
• 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: 6527399
• MDR Text Key: 74025265
• Report Number: 1625507-2017-00018
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 10885074106486
• UDI-Public: 10885074106486
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K020069
• 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: 04/26/2017

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
• Device Operator: Health Professional
• Device Model Number: EM100-A
• Device Catalogue Number: EM100-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2016
• 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