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

Model Number	TN45RCD
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for evaluation.A product analysis has not been performed.
Event or Problem Description
The customer reported the bur broke during use.There was no injury reported as a result of this event.No fragments of the blade were left inside the patient.
Additional Manufacturer Narrative
Additional information: patient information: age - (b)(6).Sex - (b)(6).Correction: date of event: (b)(6) 2017.The product analysis indicates one opened sample, part number tn45rcd, from lot number 0213692764 was received.Analysis results indicated that there was a residue consistent with biological contaminants on the device.The tip of the bur broke off at the shaft which would have resulted in the reported event.The portion that became detached measured 0.25¿ long.When viewed under magnification, the break is consistent with shear or bending stress.The plastic insert that is placed inside the distal end of the outer tube was worn which is consistent with excess pressure applied to the bur during use.There was no evidence of improper manufacturing.The information most likely indicates the break was the result of aggressive use.The device condition was out of specification as it relates to the complaint.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: 7128482
• Report Number: 1045254-2017-00465
• Device Sequence Number: 1288197
• Product Code: ERL
• UDI-Device Identifier: 00613994776266
• UDI-Public: 00613994776266
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 01/11/2019
• Device Model Number: TN45RCD
• Device Catalogue Number: TN45RCD
• Device Lot Number: 0213692764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR