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

Model Number	1884002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product analysis is not available; the device has not been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the tip of the blade broke within 30 seconds of use during a fess procedure.No fragments remained in the patient or operating area, and a new blade was opened to continue the surgery with no impact to the patient.
Additional Manufacturer Narrative
One opened sample of part number 1884002, from lot number hg1ym5x was returned for analysis.Visually, the distal tip had broken off the inner cutter which would have resulted in the reported event; the detached portion measured approximately 0.24¿ in length.The break occurred at the first proximal tooth valley, and the assemblies were deformed in a way that indicates the inner blade teeth impacted the outer cutting edge at the third proximal tooth and valley while moving in a clockwise direction.There was no evidence of concentricity issues or bends in the returned tube/shaft assemblies.There was no evidence of misuse or mishandling, and 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: 7774143
• Report Number: 3004209178-2018-17997
• Device Sequence Number: 1118797
• Product Code: EQJ
• UDI-Device Identifier: 20681490047443
• UDI-Public: 20681490047443
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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: 07/19/2025
• Device Model Number: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: HG1YM5X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1