MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - STYLUS TRANSNASAL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	TN40RCD
Medical Device Problem Codes	Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The health care provider (hcp) reported via manufacturer representative that the bur's tip was separate and loose prior to the procedure.They just opened the package and noticed that the bur was loose from the outer part and cannot be used at all.This was the first time the bur was used.There was no patient involvement.
Additional Manufacturer Narrative
Analysis found that a portion of the head / shaft was broken and removed from the outer assembly when received.The portion of the assembly removed measured 5.69¿ from tip to break point.The break point at the proximal end corresponds to the distal side of the tack weld on the tang.The configuration of the shaft break is consistent with shear [or bending] stress.The bur tang is welded onto the shaft during production using the miyachi unitek welder.A similar reserve sample bur (part number tn30mcd) was previously installed into a handpiece while ¿incrementally¿ inserting the bur; it was intentionally side loaded in all directions in an attempt to break the shaft during loading however the shaft did not break.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - STYLUS TRANSNASAL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8508571
• Report Number: 1045254-2019-00181
• Device Sequence Number: 16419974
• Product Code: ERL
• UDI-Device Identifier: 00613994776242
• UDI-Public: 00613994776242
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K081277
• 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): 05/13/2019

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: 01/04/2020
• Device Model Number: TN40RCD
• Device Catalogue Number: TN40RCD
• Device Lot Number: 0215833912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1