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

Model Number	1884012EM
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported, during an ethmoidectomy surgery, the distal portion of the blade broke off and into the patient.The surgeon was able to retrieve the blade fragment without additional equipment.A second blade was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884012em from lot number 0210093699 was received.There was a residue consistent with biological contaminants on the device.A portion of the tracker plug / wire was cut off when received which is typical for handling purposes and is not related to the complaint.A microscope and an m4 handpiece were used to evaluate the device.Visually, the tip of the middle assembly had become detached at the distal end of the spiral wrap which would have resulted in the reported event.The portion that became detached measured 0.46¿ in length.An additional fragment of the spiral wrap was returned which measured 0.15¿ in length.When viewed under magnification, there was damage to the hub that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism; and locking area damage caused by the back side of the front collet of the handpiece.Improperly loading a blade into a handpiece would result in instability between the component assemblies.Even with the deformation of the hubs, functionally, the blade loaded securely into a handpiece.There were no loose components and no damage to the teeth.The inner assembly spins and the remainder of the middle assembly indexes freely by hand.There was no allegation of a defect prior to use.The reported issue was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® SYSTEM NAVIGATED 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: 7040764
• Report Number: 1045254-2017-00411
• Device Sequence Number: 11272093
• Product Code: HAW
• UDI-Device Identifier: 00613994617415
• UDI-Public: 00613994617415
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 02/02/2018

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: 08/24/2017
• Device Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Device Lot Number: 0210093699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1