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

Model Number	1883519HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
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 professional (hcp) reported via a manufacturer representative that the blade broke shortly after use during a functional endoscopic sinus surgery (fess) procedure.The device did not break into pieces.There was a delay of less than an hour.The blade was switched out to complete the procedure.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that the inner assembly showed resistance while spinning by hand.The inner hub was pushed away from the front hub by approximately.09¿.There was no damage to the tip.When viewed under magnification, there was damage to the hubs: dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; and locking area deformation caused by the back side of the front collet of the handpiece.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: 8288324
• Report Number: 3004209178-2019-02012
• Device Sequence Number: 16819787
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 10/31/2022
• Device Model Number: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: HG2XP3J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1