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

Model Number	1883672HS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the device, a small plastic container, and an open pouch were returned in a triple plastic bag.Upon receipt, the pouch was open on three of the four sides.The small plastic container contained a broken tip.Traces of contamination were observed on the outer tube and the broken tip.No damage was noted to the outer tube or the hubs.However, the tip was detached from the spiral wrap, and striations were observed on the inner shaft.Functional testing could not be performed due to the damaged condition of the device upon return.The complaint was confirmed, due to an out of specification condition.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 drill tip broke off into patient's frontal sinus whilst in use.The item required delicate extraction as it had a sharp point where it had broken off in the internal shaft of the item.Intervention performed.The procedure was completed with backup product.There is no known patient impact.Additional information states that perioperative team and can confirm that the patient had to endure additional anaesthetic time, due to the additional drilling that was required to ensure all remnants of the remaining fragments were removed without incident.No staff member was injured in this scenario.

• 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: 25466896
• Report Number: 9612501-2026-01585
• Device Sequence Number: 15914526
• Product Code: EQJ
• UDI-Device Identifier: 00763000041052
• UDI-Public: (01)00763000041052(17)321209(10)0230253143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0230253143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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