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

Model Number	1884008
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned for evaluation.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 that in the beginning of the uppp procedure, the blade tip broke inside the tube.There were no fragments, but a new blade had to be used to complete the procedure.There was no patient injury as a result.
Additional Manufacturer Narrative
The blade was returned for analysis; during the analysis the customer report of a broken tip was not confirmed.There was damage to the hub in the locking areas caused by the locking mechanism of the handpiece.The hub damage is consistent with not being securely loaded into the handpiece, which prevented the drive mechanism of the handpiece to engage the inner hub chevrons.When loaded into a test handpiece, the blade was secured and operated in oscillation mode at 1500 rpm.As it relates to the complaint, there were no functional defects or breakages found with the returned sample blade.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: 7298522
• Report Number: 3004209178-2018-04017
• Device Sequence Number: 16462816
• Product Code: EQJ
• UDI-Device Identifier: 20681490047481
• UDI-Public: 20681490047481
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 04/12/2025
• Device Model Number: 1884008
• Device Catalogue Number: 1884008
• Device Lot Number: HG1SQRR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1