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

Device Problems Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

The completed product analysis confirmed that one opened sample of part number 1884080em from lot number 0215334243 and was manufactured april 25, 2018; there was a residue consistent with biological contaminants on the device.The reported failure was that the tip of the blade broke off , and visually, the distal tip had broken off the inner cutter, resulting in the reported event.The portion that became detached measured approximately 0.25¿ in length, where the break occurred at the first proximal tooth valley.The outer assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 4th proximal valley while moving in a clockwise direction.There was excess wear on the shaft 0.625¿ from the distal face of the inner hub, which can occur with excess pressure being applied to the blade during use; however, it is more likely the wear is a symptom of the breakage.There was no evidence of concentricity issues or bending in the outer tube, and uneven wear at the cutting tip may indicate an interference fit between the inner and outer assemblies at the tip.The customer complaint was confirmed, and there was an out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the tip of the blade broke off while using it normally.The tip was recovered from the sinus without any additional issues.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7680305
• MDR Text Key: 114015425
• Report Number: 1045254-2018-00294
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00613994617422
• UDI-Public: 00613994617422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Device Lot Number: 0215334243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 04/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 91