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

Model Number	EM210RF
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during servicing stylus touch handpiece was overheating.There was no patient involvement.
Additional Manufacturer Narrative
H3: product analysis found no fault with the device.Pre-temperature test performed for 1 minute run found max temperature of 79.1f, which is within the acceptable limit of 118f, which does not meet the reporting criteria.Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 80 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 19199583
• Report Number: 1045254-2024-00620
• Device Sequence Number: 18130621
• Product Code: HBE
• UDI-Device Identifier: 00643169945371
• UDI-Public: 00643169945371
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: Other
• Device Model Number: EM210RF
• Device Catalogue Number: EM210RF
• Device Lot Number: 215517674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown