MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number 31152090E

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).: in response to medtronic¿s request for device return, the device was returned to the manufacturer for evaluation.Analysis found the tip was broke off (not worn down), and the break was consistent with a lateral load; in conjunction, the distal inside diameter of the outer tube was worn in a lateral direction which likely indicates extended use and/or excess force was being applied.The tip was not returned and would have measured approximately 2mm.

Event Description

It was reported that the tip of a 2mm 90mm long 20deg stainless steel visao bur disappeared intraoperatively during a tympanoplasty surgery.The physician was under the impression that the tip was worn down and when questioned about the possibility of the tip remaining in the patient in the event it broke/bent instead the physician's response was it will be okay and that there was no issue.The procedure was completed successfully and without delay using another device.This is the only information provided and there was also no report of patient impact or injury as a result of this event.

• Brand Name: XPS® BUR
• 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 drive north; jacksonville FL 32216
• Manufacturer Contact: jacklyn hayman ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9042812769
• MDR Report Key: 5215305
• MDR Text Key: 31090729
• Report Number: 1045254-2015-00366
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 10/13/2015

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: 31152090E
• Device Catalogue Number: 31152090E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1