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 Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.The device was tested and the temperature rise was measured to be 68.7°f.The rate of temperature rise was above threshold at 6.8°f/sec.The likely cause was identified as worn rear bearings.It was also noted that the device was noisy, the shaft was broken and the device failed the patient current leakage test.This type of failure is associated with (b)(4).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.We will continue to track and trend this complaint type.Initial reporter phone number: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Repair request initiated for device with the report of overheating and noise.It was reported that there was no patient or staff impact.Repair request escalated to a product event based on reason for return.On follow up it was confirmed that there was no patient or staff impact as the device was tested before the patient was brought inside the operating room.

• 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: 9375057
• Report Number: 1625507-2019-00125
• Device Sequence Number: 3091131
• Product Code: HBE
• UDI-Device Identifier: 00763000174859
• UDI-Public: 00763000174859
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K012456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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
• 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: 10/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1