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 Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No analysis is available.The device has not been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The surgeon reported that the tip of the bur broke during the procedure; the initial information indicated that the surgeon hurt his hand as a result, but the follow-up stated that there was no medical attention or intervention necessary after the fact.
Additional Manufacturer Narrative
The completed analysis confirmed that one opened sample of part number tn40rcd from lot number 0214193388 was received.The reported failure/malfunction was that the tip of the bur broke during the procedure.Visually, the tip of the bur was broken off which would have resulted in the reported event; the detached portion was not returned.The bur was destructively disassembled for the analysis to remove the shaft assembly.The break occurred 0.08¿ from the proximal end of the step-down diameter and would have resulted in a portion breaking off measuring approximately 2¿ long.The fracture contained circular patterns which likely indicates torsional overload.The ifu warns, do not use excessive force to pry or push bone with the attachment or tool during dissection, as this could cause the tool to break.In conclusion, there was an out of specification condition identified as it relates to the complaint (due to physical damage).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The surgeon reported that the tip of the bur broke during the procedure; the initial information indicated that the surgeon hurt his hand as a result, but the follow-up stated that there was no medical attention or intervention necessary after the fact.
Additional Manufacturer Narrative
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: 7638729
• Report Number: 1045254-2018-00263
• Device Sequence Number: 1424713
• Product Code: ERL
• UDI-Device Identifier: 00613994776242
• UDI-Public: 00613994776242
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 04/06/2019
• Device Model Number: TN40RCD
• Device Catalogue Number: TN40RCD
• Device Lot Number: 0214193388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 08/08/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1