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	08/10/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that pre-op, the skeeter burs were wobbling after insertion.All the four burs were tested with same handpiece.The procedure was completed using other burs.There was no patient involvement.
Additional Manufacturer Narrative
H3: product analysis of the device found that visually, the packaging pouch was opened on 3 of the 4 sides and there was no damage to the packaging tray.However, the shaft was marginally bent 1.88 inches from the distal end of the diamond grit tip.Under magnification, there were scratches in the shank upon return.The overall length of the device shall be 3.850 +0.015/-0.010 inches, and the actual measurement was 3.86 inches which was in specification.The outside diameter of the sleeve shall be 0.062 ± 0.001 inches, and the actual measurement was 0.063 inches which was in specification.For further analysis, the outside diameter of the shank was 0.058 inches.Functionally, the bur securely fit into a handpiece, but while running in forward mode excessive wobbling and grinding were observed.H6: previously applied codes of fdm b17, fdr c20 and fdc d16 are no longer applicable.Previously applied additional code of img g04041 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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.
Additional Manufacturer Narrative
H6: previous analysis findings " for further analysis, the outside diameter of the shank was 0.058 inches." is 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.
Additional Manufacturer Narrative
H3: product analysis further found, after following the steps in the ifu for loading the bur into the handpiece, the bur was securely loaded into the handpiece and no wobbling was observed while running up to 12 ,000rpm.In the returned condition, there was no out of specification condition that was related to the complaint.H6: previously applied codes fdr c070605 and img g04112 are no longer applicable.Img g04041 is 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: 20145621
• Report Number: 9612501-2024-02219
• Device Sequence Number: 4236670
• Product Code: EQJ
• UDI-Device Identifier: 00763000036065
• UDI-Public: 00763000036065
• 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,Followup,Followup
• Report Date (Section B): 04/21/2025

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: 3155646
• Device Catalogue Number: 3155646
• Device Lot Number: 0226042751
• 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: 08/11/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 02/05/2025; 03/26/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/03/2025; 03/03/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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