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); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis found that the reported ¿root¿ was referring to the hub.Visually, the tracker hub came loose from the outer hub which would have resulted in the reported event.The portion that became detached is not likely to become an un-retrieved device fragment.The hubs shall be bonded to the assembly using adhesive per the drawing.When viewed under magnification there was a residue consistent with adhesive on the mounting areas.Although it appears that adhesive was present, the information indicates there was insufficient adhesion which resulted in the component coming loose.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 the blade was damaged.The white plastic of the root loosened when using the device during an endoscopic sinus surgery (ess) procedure.It was noted that there were no broken pieces that was left inside the patient's body.There was no intervention planned or performed and there was no delay in the procedure as a result of this event.The procedure was completed using a spare device.There was no patient impact or injury.

• 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: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 8759618
• MDR Text Key: 150008386
• Report Number: 1045254-2019-00325
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Device Lot Number: 0216766414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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