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

Model Number	1884002HRE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.  a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that during a functional endoscopic sinus surgery (fess) procedure, the inner blade caught the outer sheath of the blade and continued to shear out.It was the initial use of the blade.There was no intervention planned or performed as a result of this event.There was no broken pieces left inside the patient's body.It was noted that there was no delay in the procedure and the procedure was completed using a back-up device.The patient was alive with no injury.
Additional Manufacturer Narrative
Analysis found that visually, the inner distal tip cutting edge impacted the outer cutting edge which would have resulted in the reported event.No portion of the device became detached.The impact occurred at the 1st and 4th proximal tooth valley.It could not be determined if the expanded tip outside diameter was machined / turned.The outer assembly was deformed in such a way that indicates the inner blade teeth impacted the outer cutting edge while moving in a cw direction.There was no observable evidence of concentricity issues or bends.There were no signs of misuse or mishandling.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8613783
• Report Number: 3004209178-2019-09677
• Device Sequence Number: 2663000
• Product Code: EQJ
• UDI-Device Identifier: 00885074080994
• UDI-Public: 00885074080994
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/24/2019

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: 12/20/2022
• Device Model Number: 1884002HRE
• Device Catalogue Number: 1884002HRE
• Device Lot Number: HG320V6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1