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

Model Number	3155646
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pre-operatively, the bur was placed in the skeeter handpiece and presented noticeable oscillation, so it was placed in a second skeeter but the oscillation problem persisted.When a second bur was opened, it also presented the same problem in both handpieces but with less intensity.The burs were not used on the patient.The handpieces are working fine.There was no patient involved.
Additional Manufacturer Narrative
H3: product analysis confirmed visually, the mid-section of the shaft was bent when returned and there was a white residue on the distal diamond grit tip.The overall length of the bur shall be 3.850 +0.015/-0.010 inches and the actual measurement was 3.860 inches which was in specification.The outside diameter of the sleeve area shall be 0.062 ± 0.001 inches and the actual measurement was 0.058 inches which was out of specification.Functionally, the bur could not fit securely into a handpiece and while running in forward mode at 16,000rpm there was excessive wobbling.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint.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: 19698563
• Report Number: 9612501-2024-01681
• Device Sequence Number: 3701395
• Product Code: EQJ
• UDI-Device Identifier: 00763000036065
• UDI-Public: 00763000036065
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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: Health Professional
• Device Model Number: 3155646
• Device Catalogue Number: 3155646
• Device Lot Number: 0224390785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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