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

Model Number	1884002HRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visually, the distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached measured approximately 0.23¿ in length.The break occurred at the first proximal tooth valley and continued to the 3rd proximal valley.The proximal end of the expanded tip outside diameter was rough and worn which may indicate aggressive use.The outer and inner assembly were deformed in such a way that indicates an impact occurred at the 1st and 3rd proximal valley while moving in oscillate mode which resulted in the observed break.There was no evidence of concentricity issues or bend in the outer tube.When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device into the handpiece: dimples on the front hub prior to the locking area caused by a misalignment of the handpiece locking mechanism; locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism.There was deformation of the hub locking area consistent with aggressive use.The information most likely indicates erratic torsional loads due to aggressive use and improper loading caused the break.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that a blade tip was damaged.There was no patient impact.The procedure was completed with backup product.

• 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: 9641351
• Report Number: 3004209178-2020-02070
• Device Sequence Number: 11254002
• Product Code: EQJ
• UDI-Device Identifier: 00885074080994
• UDI-Public: 00885074080994
• 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): 01/29/2020

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 Expiration Date: 02/24/2021
• Device Model Number: 1884002HRE
• Device Catalogue Number: 1884002HRE
• Device Lot Number: HG1PEDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1