MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING; BUR, EAR, NOSE AND THROAT

Model Number	1884080EM
Medical Device Problem Codes	Material Separation (1562); Obstruction of Flow (2423)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the tip of the blade broke off in the patient.There was no patient impact reported.
Additional Manufacturer Narrative
Analysis found that visually, the distal tip had broken off the inner cutter.The portion that became detached measured approximately 0.24¿ in length.The break occurred at the first proximal tooth valley.The assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer cutting edge at the 1st proximal tooth while moving in a ccw direction which resulted in the observed break.There was no evidence of concentricity issues or bends in the returned tube / shaft assemblies.There was minor wear on the shaft 0.56¿ from the distal face of the inner hub.There was uneven wear at the cutting tip as well.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the health care provider (hcp) reported that there were two different shavers; one in the middle of a case clogged a couple of times and then the tip of the inner blade shaft broke off and fell into the patient.There was no patient impact or injury.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7945151
• Report Number: 1045254-2018-00480
• Device Sequence Number: 14037812
• Product Code: EQJ
• UDI-Device Identifier: 00613994617422
• UDI-Public: 00613994617422
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2018

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: 07/07/2020
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Device Lot Number: 0215860494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 11/20/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/15/2018; 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1