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

Model Number	1882569HS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider reported via manufacturer representative that the bur head broke off inside the patient.The hcp used a dcr bur at 30,000 rpm instead of the indicated 12,000 rpm.The bur head was removed, an x-ray was performed to check that no metal remained in the patient.The procedure was delayed for 60 minutes.The bur was stuck inside the handpiece.A different handpiece was used to finish the procedure.The patient was not injured.

• 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: 9738993
• Report Number: 1045254-2020-00100
• Device Sequence Number: 19283181
• Product Code: EQJ
• UDI-Device Identifier: 20721902978009
• UDI-Public: 20721902978009
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: 1882569HS
• Device Catalogue Number: 1882569HS
• Device Lot Number: 0212447183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention