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

Model Number	EM210RF
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis found that drill was not running due to motor failure.Unit could not be tested and was scrapped.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via manufacturer representative that the device was not working properly.There was no patient or staff impact.On follow-up, it was reported that chatter or vibration was noted on the device during the procedure while being used on patient.

• 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: 12216818
• Report Number: 1045254-2021-00389
• Device Sequence Number: 17218891
• Product Code: HBE
• UDI-Device Identifier: 00643169945371
• UDI-Public: 00643169945371
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/23/2021

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: EM210RF
• Device Catalogue Number: EM210RF
• Device Lot Number: 213039283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1