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

Model Number EM200-R

Device Problems Overheating of Device (1437); Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Chemical Exposure (2570)

Event Date 03/05/2020

Event Type  Injury  

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 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
• 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: allison evertz-hammel ; 4620 north beach street; ft. worth, TX 76137-3291 ; 7625263173
• MDR Report Key: 9920551
• MDR Text Key: 193626995
• Report Number: 1625507-2020-00045
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00613994422002
• UDI-Public: 00613994422002
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2008
• 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
• Patient Outcome(s): Other