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

Model Number	1882569HS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.
Event or Problem Description
It was reported that a high speed bur broke off 2cm from the tip and into the patient.The broken piece was retrieved without complications.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1882569hs from lot number 0210549401 was received.Visually, the tip was broken off which would have resulted in the reported event.The portion that broke off measured approximately 1.24¿.The break occurred at 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, which likely indicates bending/prying forces applied to the bur tip.There was no allegation of a defect prior to use.There are checks for damage throughout the manufacturing process.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates bending/prying forces resulted in the wear and excess torsional load, which caused the breakage of the spiral wrap.The ifu warns that excessive pressure applied to bur may cause bur fracture, and bending or prying may break the blade or bur.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 n; jacksonville FL 32216
• MDR Report Key: 6450382
• Report Number: 1045254-2017-00106
• Device Sequence Number: 874525
• Product Code: EQJ
• UDI-Device Identifier: 20721902978009
• UDI-Public: 20721902978009
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2017

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: 12/08/2019
• Device Model Number: 1882569HS
• Device Catalogue Number: 1882569HS
• Device Lot Number: 0210549401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 06/27/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 07/21/2017; 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1