MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC HANDPIECE - STYLUS TOUCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	EM210
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis : temp.Check was not performed due to motor froze.Handpiece will not work due to motor/collet froze.Unit had to be scrapped, physically damaged.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via manufacturer representative that a handpiece was not working properly.There was no known patient impact.On follow up it was reported that the motor overheated during first minute of surgery.Another drill was used.No patient or staff impact.

• Brand Name: IPC HANDPIECE - STYLUS TOUCH
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 12238534
• Report Number: 1045254-2021-00403
• Device Sequence Number: 17060910
• Product Code: HBE
• UDI-Device Identifier: 00613994633897
• UDI-Public: 00613994633897
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: EM210
• Device Catalogue Number: EM210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1