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

Model Number	31202090E
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: there will be 2 reports filed with the same patient identifier, (b)(6); one for each of the two burs that broke during the same procedure.Product evaluation: analysis results are not available; device not returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The facility reported that during the procedure, the tip of each of the two burs "broke off though it was not pressed hard".The fragments were retrieved with "tweezers" and it was" confirmed that there was no remaining tip/fragment by viewing microscope".There was no patient impact.
Additional Manufacturer Narrative
Product evaluation: bur 31202090e visao 2mm: 1 opened sample, part number 31202090e, from lot number 0213057276 was received for analysis.Visually, the round diamond tip with a portion of the shaft broke off which would have resulted in the reported event.The portion that broke off measured 0.114¿ in overall length.The configuration of the fractured surface (shaft) is consistent with a sheer or bending stress.The customer indicated the break occurred during use with no allegation of a defect prior to use.The ifu warns that excessive pressure applied to bur may cause bur fracture, and bending or prying may break the blade or bur.There were wear marks on the shaft surrounding the break and corresponding wear to the inside diameter of the outer tube which is consistent with aggressive use.The information most likely indicates the bur was subjected to aggressive use which resulted in excess wear and shaft breakage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6952654
• Report Number: 1045254-2017-00369
• Device Sequence Number: 682443
• Product Code: EQJ
• UDI-Device Identifier: 00885074154046
• UDI-Public: 00885074154046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/16/2017

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: 03/29/2021
• Device Model Number: 31202090E
• Device Catalogue Number: 31202090E
• Device Lot Number: 0213057276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1