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

Model Number	1884016HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Device evaluation anticipated but not yet begun.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the rad 60 blade tip detached as soon as the operator began using the blade during an endoscopic sinus surgery procedure.No fragment resulted from the breakage.There was no patient impact reported as a result of this event.The procedure was completed with a back-up device.
Additional Manufacturer Narrative
The product analysis was completed.One opened sample of part number 1884016hr, from lot number [no information] was received.The middle assembly tip had broken off at the spiral wrap which would have resulted in the reported event.The portion that became detached measured 0.46¿ long.The middle assembly would bind when turned by hand which is an indication internal damage or interference between assemblies.When viewed under magnification, there was deformation of the locking area that is consistent with excess pressure applied to the blade while in the handpiece.The middle tube spiral wrap outside diameter shall measure 0.1470¿ +0.0010¿ / -0.0000¿; the shrink tube shall have a nominal wall thickness of 0.0010¿ / +-0.0002¿ (some variability may occur after shrinking it on to the tube); the outer tube sheath inside diameter shall measure 0.160¿ / +-0.001¿.The outside diameter of the outer tube sheath reduced by as much as 0.012¿ in the radius / curve (0.184¿ to 0.172¿).Providing the wall thickness of the outer tube sheath had no significant change from the distal end to the radius / curve, by extrapolation - the range of clearance between assemblies, using the allowed tolerance, would be approximately 0.000¿ clearance to 0.003¿ interference fit.The clearance combined with the binding of the middle assemblies indicates insufficient clearance for proper function.It is possible the excess pressure resulted in deformation of the assemblies reducing the clearance; however, it is unlikely due to the strength of materials used in the outer tube sheath.The information more likely indicates the reduction of the diameter (flattening) occurred during the bending step in manufacturing.Due to the likely manufactured deformation of the components, it is likely that the user experience improper cutting / operation and in an attempt to resolve this, applied excess pressure.The device condition was out of specification as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.

• 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: 7123122
• Report Number: 1045254-2017-00461
• Device Sequence Number: 19282249
• Product Code: EQJ
• UDI-Device Identifier: 20885074080646
• UDI-Public: 20885074080646
• 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): 02/01/2018

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 Model Number: 1884016HR
• Device Catalogue Number: 1884016HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/15/2017
• 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