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 Burn(s) (1757)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.Evaluation could not be performed because the device stalled and seized with error code 15.It was noted that the shaft was broken.This finding may have contributed to the user's experience.It was also noted that part of the collet marking was missing.No conclusions available for the attachments involved in the event as these devices were not returned.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 46 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 after the craniotomy procedure, the nurse's hands got blistered after attempting to change the attachment.It was stated that the motor was extremely hot to touch.It was reported that there was no patient impact.On follow up, it was confirmed that the nurse had no further issues post-surgery.No further information can be provided for the attachments serial numbers.

• 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: allison evertz-hammel ; 4620 north beach street; ft. worth, TX 76137-3291 ; 7635263173
• MDR Report Key: 10101757
• MDR Text Key: 193625281
• Report Number: 1625507-2020-00072
• Device Sequence Number: 1
• Product Code: HBE
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• 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: 05/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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
• Patient Outcome(s): Other