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

Model Number	TN30MFL
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that when the shaft was turned by hand using the head of the bur while viewing the drive mechanism [the bur tang], the tang was not turning which indicated a broken shaft.The shaft was removed from the assembly for further analysis, it measured 5.70¿ 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 shape of the shaft break is consistent with shear [or bending] stress.There was some discoloration next to the break.A similar reserve sample bur 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; the shaft did not break.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via a manufacturer representative that the bur on the handpiece would not turn when the footswitch was pressed.Another bur was used on the handpiece and worked fine.There was no patient impact.

• 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: 8059480
• Report Number: 1045254-2018-00584
• Device Sequence Number: 19329514
• Product Code: ERL
• UDI-Device Identifier: 00613994776211
• UDI-Public: 00613994776211
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2019
• Device Model Number: TN30MFL
• Device Catalogue Number: TN30MFL
• Device Lot Number: 0214264154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1