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

Model Number	1882969
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: analysis results not available; device not received for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The surgeon reported that during a dcr "the bur broke inside cavity nasal of the patient.The bur was being used at <6000rpm." "the drill fragment was recovered after radiography, we had to retract the palate with aspiration probe and removed the fragment that was housed in the cavum"; the fragment was removed orally after x-ray confirmation of location.There was no patient injury.
Additional Manufacturer Narrative
Product evaluation: the curved dcr 2.9mm bur was receive for analysis.Visually, the tip was broken off which would have resulted in the reported event.The portion that broke off was not returned however the portion would have measured approximately 0.3¿.The break occurred approximately half way down the spiral wrap which was twisted in on itself in a clockwise direction indicating excess torsional load.The inside diameter of the outer tube at the distal end was worn through the wall which likely indicates bending / prying forces applied to the bur tip.The information indicates that bending / prying forces most likely resulted in the wear and excess torsional load which caused the breakage of the spiral wrap.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6642068
• Report Number: 1045254-2017-00189
• Device Sequence Number: 1049439
• Product Code: EQJ
• UDI-Device Identifier: 20681490613273
• UDI-Public: 20681490613273
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: 1882969
• Device Catalogue Number: 1882969
• Device Lot Number: 0209966060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 06/27/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 07/19/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention