MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1882900
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that there were multiple burs affected, one reported to have broken and others not drilling or "blunt" during the procedure.The patient was alive with no injury.On follow-up, it was reported that the procedure was comprehensive endoscopic sinus surgery with frontal trephines.The hcp had to open more than one drill on a case as compared to usually just using one drill per case.There were fragments detached from the device.There was a delay in the procedure because the drill was not drilling into the patient¿s bone so the procedure took longer.
Additional Manufacturer Narrative
Analysis found that visually, the distal end of the inner shaft broke off.The portion that became detached measured 0.70¿ long.The break point corresponds to the distal end of the outer hub.Visually, there was wear on the inner shaft and on the adjacent faces of the hubs.There was a residue consistent with tape adhesive on the hubs.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8239305
• Report Number: 1045254-2019-00016
• Device Sequence Number: 11310100
• Product Code: EQJ
• UDI-Device Identifier: 00681490047241
• UDI-Public: 00681490047241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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 Expiration Date: 03/19/2026
• Device Model Number: 1882900
• Device Catalogue Number: 1882900
• Device Lot Number: 0215115426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1