MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884006HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicated one opened sample of part number 1884006hr from lot number hg1r4z7 was received.A microscope and cal ipers were used to evaluate the device.Visually, the middle tube tip broke off at the spiral wrap and the inner spiral wrap was stretched which would have resulted in the reported event.The tip fragment measured 0.6¿ long.The inner shaft contained striations 0.48¿ from the distal face of the inner hub.The striations correspond to the proximal end of the outer tube in the front hub indicating metal on metal contact which is consistent with excess pressure applied to the blade during use.When viewed under magnification, there was deformation of the locking area on the front hub which is also an indication of excess pressure.There was no allegation of a defect prior to use.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; creating excess torsional load; and resulting in the spiral wrap breakage / stretch.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the rad40 curved blade stopped working during endoscopic sinus surgery (ess).The procedure was completed with a back-up product.The blade has some type of damage, but it is not broken.There was no patient impact or injury reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information indicated that the tip of the blade was probably intact while in use.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7175991
• Report Number: 3004209178-2018-00476
• Device Sequence Number: 16597472
• Product Code: EQJ
• UDI-Device Identifier: 20885074080585
• UDI-Public: 20885074080585
• 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): 01/16/2018

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: 03/21/2021
• Device Model Number: 1884006HR
• Device Catalogue Number: 1884006HR
• Device Lot Number: HG1R4Z7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1