MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1882905HRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis result indicates that the distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached was not returned but would have measured approximately 0.17¿ in length.The break occurred at the first proximal tooth valley.The outer assembly cutting tip was deformed in such a way that indicates the inner blade teeth impacted the outer teeth while moving in a cw direction which resulted in the observed break.All teeth on one side were impacted, decreasing in severity toward the distal end.The teeth on the other side showed some wear.There was a light coating of grease on the inner assembly as required.The expanded tip was rough and worn on the proximal side, it did not appear to be machined.The adjacent inside diameter of the outer tube was rough and worn which may indicate excessive friction due to the deformation of the teeth.There was no evidence of concentricity issues or bends in the outer tube or inner cutter.There were no signs of improperly loading the blade in the handpiece or excess pressure being applied during use.There was no allegation of a defect prior to use.Excess speed or direction cannot be ruled out as a potential cause however the information more likely indicates the blade came in contact with an inappropriate material during cutting.In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage).The most likely underlying cause is consistent with, misuse / use error.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that the blade broke intra operatively.Customer used back-up product to complete the procedure with no issues.No patient injury and no delay in procedure.Nothing broke off in patient or was left inside patient.Additional information received from rep stating that the blade did not have fragments.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9902079
• Report Number: 1045254-2020-00193
• Device Sequence Number: 16829708
• Product Code: EQJ
• UDI-Device Identifier: 00763000036782
• UDI-Public: 00763000036782
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: 09/12/2023
• Device Model Number: 1882905HRE
• Device Catalogue Number: 1882905HRE
• Device Lot Number: 0218283719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 DA
• Patient Weight: 2