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

Model Number 1884004

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

The blade has not been returned for evaluation.A product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that during a procedure, the surgeon indicated the blade was not working.When he took the blade out of the patient to examine the blade, the tip of the blade had broken off.The nurse saw the tip on the endoscope monitor and retrieved the tip of the blade.There was no patient injury.

Manufacturer Narrative

Product analysis indicates one opened sample, part number 1884002, from lot number [no information] was received.There was a residue consistent with biological contaminants on the device.Although the reported part number was 1884004, the configuration of the device is consistent with the part number as stated above.The distal tip had broken off the inner cutter which would have resulted in the reported event [the tip of the blade had broken off].The portion that became detached measured approximately 0.25¿ in length.The break occurred at the first proximal tooth valley.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.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 device lot is not available as the package was discarded.A fess (functional endoscopic sinus surgery) was performed.Using the scope, the surgeon was able to identify the fragment and retrieved the fragment.

• 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: angie demo ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328355
• MDR Report Key: 7120650
• MDR Text Key: 95075663
• Report Number: 1045254-2017-00458
• Device Sequence Number: 1
• Product Code: EQJ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1