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

Model Number 1884560HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not performed; product was not returned for analysis.

Event Description

It was reported that during a dacryocystorhinostomy two round burs broke.The break did not result in fragments.There was no impact to the patient.

Manufacturer Narrative

(b)(4).Device returned on nov 4, 2016.Concomitant products: 1884560hs: 3pk round hi speed bur 4.5mm, lot, manufactured date and expiration date are unknown, udi # (b)(4).Date mfr.Rec: 11/28/2016.Two burs from part number 1884560hs was involved in this event.One of the devices from part number 1884560hs was not returned since it was discarded by the facility.The second bur from part number 1884560hs was returned.When this bur was compared to the assembly drawing: the inner shaft was broke 0.66¿ from the distal face of the inner hub which would have resulted in the reported malfunction.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there was deformation of the front hub and striations around the outside diameter of the break point indicating metal on metal contact.The inner shaft showed abrasions in the support area 0.7¿ form the distal tip.The information most likely indicates excess pressure was applied during use which caused the deformation of the front hub; which then caused the inner shaft and outer tube to rub together until the inner shaft broke.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.Instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.(b)(4).

Manufacturer Narrative

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

• Brand Name: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: sharanya jangiti ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328183
• MDR Report Key: 6086667
• MDR Text Key: 59459997
• Report Number: 1045254-2016-00385
• 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,Followup,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884560HS
• Device Catalogue Number: 1884560HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• 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