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

Model Number	EM210
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the unit will not run due to motor and collet broken and motor seized.Hence, pre-repair heat test could not be performed.The unit had to be scrapped.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the handpiece overheated prior to the procedure.There was no patient impact.

• Brand Name: IPC HANDPIECE - STYLUS TOUCH
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 11398291
• Report Number: 1045254-2021-00083
• Device Sequence Number: 16987824
• Product Code: HBE
• UDI-Device Identifier: 00643169945388
• UDI-Public: 00643169945388
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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
• Device Lot Number: 219307519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1