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

Model Number	31317062U
Medical Device Problem Codes	Material Separation (1562); Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
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 the irrigation channel snapped during a resection of acoustic neuroma procedure.The irrigation channel could not be used with the bur guard.The surgeon decided to use another handpiece with irrigation.The surgeon stated that the bur felt like it was vibrating/wobbling and then it snapped.The distal part of the bur was retrieved.The proximal part of the bur was stuck inside the drill.There was a delay in the procedure as a result of this event.There was no patient impact or injury.
Additional Manufacturer Narrative
Analysis found that the shaft of the bur broken.The measure from bur tip to break was 1.375".The break configuration is consistent with a shear or bend force.If information is provided in the future, a supplemental report will be issued.

• 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: 8202275
• Report Number: 1045254-2018-00737
• Device Sequence Number: 16192274
• Product Code: EQJ
• UDI-Device Identifier: 00885074527505
• UDI-Public: 00885074527505
• 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): 03/13/2019

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: 09/27/2021
• Device Model Number: 31317062U
• Device Catalogue Number: 31317062U
• Device Lot Number: 0214101438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 90