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

Model Number	1884012HR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis confirmed that one opened sample of part number 1884012hr from lot number hg2303k was received with a residue consistent with biological contaminants on the device.Visually, the middle assembly tip broke off at the spiral wrap which would have resulted in the reported event.The portion that broke off measured 0.466¿ long.The inner shaft and middle tube spun and indexed freely by hand.When viewed under magnification, the most distal teeth of the inner and middle assemblies showed deformation; the deformation pattern was matched to a stylette that is included with the device.There was no damage to the packaging to indicate a cause and no allegation of damage prior to use.The information most likely indicates the suction path was being cleaned out during the procedure with a stylette or similar device, and inadvertent activation of the blade / handpiece caused the teeth to impact the stylette resulting in the tip break.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the blade fell apart while being used during an endo sinus maxillary and ethmoid procedure.The tip of the blade broke off into the cavity; however, there was no patient impact or injury.

• 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: 7579573
• Report Number: 3004209178-2018-12895
• Device Sequence Number: 11144078
• Product Code: EQJ
• UDI-Device Identifier: 20885074080608
• UDI-Public: 20885074080608
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 10/19/2021
• Device Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Device Lot Number: HG2303K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1