MAUDE Adverse Event Report: MEDTRONIC DOMINICANA XPS® BUR - HIGH SPEED RAD®; BUR, EAR, NOSE AND THROAT

Model Number	1883070HS
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after using the drill for ten minutes at the time of the draf procedure, the drill was hot and the motor sounded like it was moving, but when the drill was applied to the affected area, it stopped spinning and was idle spinning.There was no patient impact.As per the bur analysis, it is wobbling.
Additional Manufacturer Narrative
H3: product analysis found that visually, the inner shaft distal to the inner hub was bent when returned and there were indentions in the chevrons on the proximal end of the inner hub.Under magnification, there was a white residue on the distal tip.Functionally, the inner assembly spun freely by hand with no binding.The bur fit securely into a handpiece, but while running in forward mode at 12,000rpm there was excessive wobbling.For further analysis, an x-ray was performed to observe the internal construction of the device and no damage was observed in the spiral wrap.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).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.
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 the draf procedure, after using the drill for ten minutes, it began overheating with a delay of more than one minute at a speed of 12,000 rpm in forward mode.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 20681261
• Report Number: 9612501-2024-02906
• Device Sequence Number: 8557369
• Product Code: EQJ
• UDI-Device Identifier: 00681490464604
• UDI-Public: 00681490464604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0225820806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown