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

Model Number	1883673HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: product receipt / condition: 1 opened sample, part number 1883673hs, from lot number 0214099193.The inner shaft broke 0.65¿ from the distal face of the inner hub which would have resulted in the reported malfunction.The break point corresponds to the proximal end of the outer tube in the front hub.There were striations around the outside diameter of the break point indicating metal on metal contact.The information indicates excess pressure was applied during use which caused the deformation of the locking area; which then caused the inner shaft and outer tube to rub together until the inner shaft broke.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that while the high speed choanal atresia bur was in use during a dacryocystorhinostomy, the base of the inner cylinder was broken.There was no patient impact or injury.The procedure was completed with backup products.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7373419
• Report Number: 1045254-2018-00131
• Device Sequence Number: 1252887
• Product Code: EQJ
• UDI-Device Identifier: 20721902686201
• UDI-Public: 20721902686201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXCEMPT
• 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
• Report Date (Section B): 03/27/2018

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: 09/25/2025
• Device Model Number: 1883673HS
• Device Catalogue Number: 1883673HS
• Device Lot Number: 0214099193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1