MAUDE Adverse Event Report: MEDTRONIC XOMED INC. 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	10/19/2020
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 via manufacturer representative reported that tip of the bur broke off in the patient's nose during the procedure.The broken pieces were retrieved from the patient's nose.The second bur opened also broke off and was retrieved.Intervention was performed to retrieve the broken pieces.The procedure was delayed for 5 minutes.The procedure was completed.The patient was unharmed.No broken pieces of the reported product remain inside the patient's body.On follow up, it was stated that there were no additional procedures or unintended equipment required to retrieve the fragment, instruments already being used in the procedure were used and no additional procedures were necessary.The event occurred during functional endoscopic sinus surgery in the front sinus.

• Brand Name: XPS BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10860239
• Report Number: 1045254-2020-00557
• Device Sequence Number: 3803069
• Product Code: EQJ
• UDI-Device Identifier: 20721902100561
• UDI-Public: 20721902100561
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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: 08/08/2024
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0211765554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1