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

Model Number	1884012HR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the middle assembly tip broke off at the spiral wrap and the inner spiral wrap was deformed which would have resulted in the reported event.The broken tip measured 0.45¿ with a piece of spiral wrap extending outward.There was uneven wear inside the middle assembly cutting mouth opening.There was grease on the inner assemblies as required by the drawing.There was deformation of the rotating hub consistent with improper loading the blade into the hand piece and excess pressure applied after being properly loaded: dimples on the front hub prior to the locking area caused by a misalignment of the hand piece locking mechanism, locking area deformation caused by the back side of the front collet of the hand piece, and elongation of the locking divots.Although there was hub deformation, the blade loaded properly into the hand piece.Although there was damage to both assemblies, the inner and middle assemblies spun freely by hand using the hubs which indicates there was no interference fit.There was no damage to the cutting teeth.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that when the new product was opened during set-up, the tip had been broken.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: 9824204
• Report Number: 3004209178-2020-05228
• Device Sequence Number: 19604758
• Product Code: EQJ
• UDI-Device Identifier: 00885074080604
• UDI-Public: 00885074080604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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 Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Device Lot Number: HG319PZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1