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

Model Number	1884012
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884012 from lot number hg1h843 was received.A microscope was used to evaluate the device.Visually, the tip was discolored in such a way that is consistent with excess heat which would have resulted in the reported event.Inside the outer tube mouth opening were small fragments stuck to the tip wall, which likely resulted in the gouging, excess wear, and friction induced heat during rotation of the blade.The fragments appear to be portions of the inner cutter tip.The cause of the fragments was likely from an impact with inappropriate material, improper speed and/or direction, or aggressive use.Note: the maximum recommended speed for this device is 5000rpm in oscillate mode / direction.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During visual inspection, small fragments were noted inside the outer tube mouth of the blade.The small fragments were stuck to the tip wall.The fragments appear to be portions of the inner cutter tip.There was no patient impact.

• 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: 7162140
• Report Number: 3004209178-2018-00183
• Device Sequence Number: 13476857
• Product Code: EQJ
• UDI-Device Identifier: 20681490047535
• UDI-Public: 20681490047535
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 01/03/2018

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: 11/21/2024
• Device Model Number: 1884012
• Device Catalogue Number: 1884012
• Device Lot Number: HG1H843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1