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	Burn(s) (1757)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.Evaluation could not be performed because the device seized.It was noted that the bearing was worn and the shaft was broken.This finding may have contributed to the user's experience.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.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the device had a malfunction and overheated.The doctor was using the perforator and he was holding it when he felt that it was getting hot.On follow-up, it was confirmed that the motor overheated and that the doctor had a burn on his thumb (white patch on skin).There was a 5-7 minutes procedure delay due to device replacement and preparation.There was no patient impact and no medical intervention done due to the injury.

• 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: 8083908
• Report Number: 1625507-2018-00070
• Device Sequence Number: 14034840
• Product Code: HBE
• UDI-Device Identifier: 00613994422002
• UDI-Public: 00613994422002
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: EM200-R
• Device Catalogue Number: EM200-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/19/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 100