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

Model Number	EM200-R
Medical Device Problem Codes	Overheating of Device (1437); Loss of Power (1475); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn for the em200.Evaluation could not be performed because the motor seized and was noisy.No conclusion can be drawn for the ad03.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.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 43 months with no record of factory service during this period.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a perforator was used together with an ad03 and em200-r during a brain tumor resection procedure.They noticed that the number of rotations only reached about 4000 and an error code 16 was displayed.At that time, overheating also occurred.There was no backup drill that could be used and the procedure was discontinued for 90 minutes.During that time, a non-medtronic drill was borrowed from a different facility to complete the procedure.On follow up, it was reported that the perforator used was a codman and it was discarded.It was also added that the patient had no further issues post-surgery.

• Brand Name: MOTOR LEGEND EHS STYLUS REFURB
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 9920551
• Report Number: 1625507-2020-00045
• Device Sequence Number: 16968209
• Product Code: HBE
• UDI-Device Identifier: 00613994422002
• UDI-Public: 00613994422002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other