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

Model Number	1884005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two opened samples of part number 1884005, from lot number 0210269571 were received.Sample 1: visually, the inner tip broke off at the first proximal valley which would have resulted in the reported event.The portion that broke off measured 0.22¿.There was wear on the inner shaft 0.55¿ from the distal face of the inner hub which may indicate aggressive use.The shape of the fracture is consistent with the breakage occurring while moving in a clockwise direction.Sample 2: visually, the inner tip was fractured approximately half way through at the first proximal valley which would have resulted in the reported event.There were no fragments that detached.The shape of the fracture is consistent with the breakage occurring while moving in a clockwise direction.The information most likely indicates the blades were use in conflict with the instructions for use and / or labeled indications.The maximum recommended speed for this device is 5000 rpm in oscillate mode / direction.The ifu warns: do not use burs above the speed indicated on the bur label.For high speed drilling (greater than 6,000 rpm) ensure that an xps high speed bur is used; bending or prying may break the blade or bur; and excessive pressure applied to bur / blade may cause bur fracture.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 facility reported that the head of two blades fractured during a procedure.There was no report of patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received indicating that tip of the blades broke.This break did result in fragments inside the patient.The doctor removed the fragments from the patient without any medical intervention.Another blade (product # 1884004) was used to complete the surgery.There was no patient impact.

• 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: 6737123
• Report Number: 1045254-2017-00252
• Device Sequence Number: 1566029
• Product Code: EQJ
• UDI-Device Identifier: 20681490047467
• UDI-Public: 20681490047467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/29/2017

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: 10/11/2023
• Device Model Number: 1884005
• Device Catalogue Number: 1884005
• Device Lot Number: 0210269571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1