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

Model Number	3155648
Medical Device Problem Codes	Vibration (1674); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that preoperatively, new bur found wobbling and slightly bent.Bent was observed as soon as it was removed from the package.There was no damage to the outer package.There was no patient involved in the event.
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.
Additional Manufacturer Narrative
H3: product analysis found that there was no significant damage noted to the packaging carton.When returned, the packaging carton contained both inserts, an open pouch, and plastic tray with a device in it.The pouch was open from 3 of 4 sides when returned.Although the bur was slightly bent upon return, it passed overall measurement.The overall length of the device shall be 3.850 +0.015/-0.010 inches, and the actual measurement was 3.856 inches which was in specification.Under the magnification, traces of contamination were observed on diamond tip and the shank.The device was loaded into a handpiece and ran up to 12 ,000rpm in forward mode.It was observed that the wobbling was more present at lower speed, and as speed was increasing, the wobbling was diminishing but still present.The complaint was confirmed, due to an out of specification condition.H6: previously submitted codes fdm b17, fdr c20 and fdc d16 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: XPS® BUR
• 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: 22491386
• Report Number: 9612501-2025-01827
• Device Sequence Number: 4097111
• Product Code: EQJ
• UDI-Device Identifier: 00763000036089
• UDI-Public: (01)00763000036089(17)300403(10)0223931456
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 08/19/2025

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: 3155648
• Device Catalogue Number: 3155648
• Device Lot Number: 0223931456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown