MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG; BUR, EAR, NOSE AND THROAT

Model Number 1884004

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported via a manufacturer representative that during a routine functional endoscopic sinus surgery (fess) procedure, the surgeon noticed that the handpiece did not feel right so they removed the blade from the patient and noticed upon checking the blade that the tip was missing.They checked the patient for any signs of metalwork or injury (none detected) and utilized a second blade from a different batch to complete the case.The missing tip was found on the drapes.The hcp compared the two tips and it appeared to have all the missing part.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG
• 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: 8200775
• MDR Text Key: 131580102
• Report Number: 1045254-2018-00735
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490047456
• UDI-Public: 00681490047456
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

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
• Device Operator: Health Professional
• Device Model Number: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: HG2S6GY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Date Device Manufactured: 08/27/2018
• 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