MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. BUR 1883673HS 3PK CHOANAL ATRESIA TAPER; BUR, EAR, NOSE AND THROAT

Model Number 1883673HS

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2013

Event Type  malfunction  

Event Description

It was reported that during the operation (dcr) the bur tip got stuck and could not use it.There was no impact on patient.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: when received for analysis, there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].When compared to the assembly drawing: the front hub showed a reduction in the outside diameter just proximal to the locking area; typically this damage has been associated with excess heat deformation.When viewed under magnification, there was some gouging of the inner shaft in the support area proximal to the tip.The shaft would turn by hand; however, it was not turning smoothly [it was gravely].The bur was installed into a handpiece, ran at 12,000 rpm in forward direction, and cut saw bone for 30 seconds; during the run the bur produced excess noise and vibration; however, it never stopped turning as reported.While removing the bur from the handpiece it was noticed that the front hub and outer tube radius were too hot to touch, even while wearing gloves.An attempt to measure the temperature using an infrared thermometer failed possibly due to the shape and size of the area being measured.The information indicates the shaft is binding.The alleged malfunction could not be confirmed, [bur tip got stuck / stopped turning] however; the excess heat may have resulted in the seizing of the bur over an extended period of time.Based off of the analysis findings alone, the underlying cause could not be determined.Method: simulated use testing.Microscopic inspection.

• Brand Name: BUR 1883673HS 3PK CHOANAL ATRESIA TAPER
• 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: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3554885
• MDR Text Key: 4050572
• Report Number: 1045254-2014-00005
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2013

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 Expiration Date: 06/15/2021
• Device Model Number: 1883673HS
• Device Catalogue Number: 1883673HS
• Device Lot Number: 0207103406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1