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

Model Number	1884002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened sample of part number 1884002, from lot number 0211465327 was returned.Evaluation indicated that visually, the inner tip was broken which would have resulted in the reported event.Contrary to the reported event, the tip was broken ¿off¿, not attached, and not returned.The break point was at the first proximal valley and proceeded to the second proximal valley.The length of the portion that broke off would have measured approximately 0.15¿.The mouth opening where the cutting action is performed showed impact marks on the outer and inner cutters consistent with the damage occurring while the blade was in forward motion.The front hub locking area was deformed and the damage was consistent with being caused by the back side of the front collet of the handpiece.The customer indicated the break occurred during surgery; this in conjunction with the deformation of the hub and tip break the information most likely indicates aggressive use such as excess pressure applied to the blade during use.The ifu warns that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure required for operation].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 customer reported that intraoperative a blade broke during the surgery.No fragment was found in the patient.The operation was delayed for less than 10 minutes.Additional information was received indicated that the tip broke, but is still attached to the shaft; there were no fragments.There was no patient impact.The product analysis of the device indicates that tip of the blade broke off not attached, and not returned.

• 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: 6619391
• Report Number: 1045254-2017-00175
• Device Sequence Number: 13456285
• Product Code: EQJ
• UDI-Device Identifier: 20681490047443
• UDI-Public: 20681490047443
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: 06/14/2024
• Device Model Number: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: 0211465327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1