MAUDE Adverse Event Report: MEDTRONIC XOMED INC. CURVED ROUND DIAMOND BUR, HIGH-SPEED; BUR, EAR, NOSE AND THROAT

Model Number 1885061HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

It was reported that the diamond bur suddenly broke off after it was used for a few seconds during the surgery.There was no debris from the broken bur.The operation was continued using a back-up device and completed successfully with no adverse effect.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: product analysis expected, but not yet begun.Method: no testing methods performed.(b)(4).

Manufacturer Narrative

Date received: december 19, 2014.Product evaluation: analysis found that when compared to the assembly drawing: the inner shaft was extremely extended and the tip was still intact.There was splaying of the chevrons noticeable without magnification striations, indicating that the bur had been loaded and run.Under magnification, three (3) indentations were found on the outer hub, proximal to the tip and equidistant from one another that coincide with the locking mechanism retention mechanism.In conjunction with the splayed chevrons, this is typical of improper loading in which the bur was not fully seated and becomes jammed.The customer included that they may have pulled on the shaft area to remove the bur, at which point it is likely the spiral wrap was stretched, however it did not completely break, and no fragments were created.Method: actual device evaluated; labeling evaluation; visual inspection.Results: deformation problem.Conclusion: use error caused or contributed to event.

Manufacturer Narrative

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

• Brand Name: CURVED ROUND DIAMOND BUR, HIGH-SPEED
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr 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: 4326458
• MDR Text Key: 15812846
• Report Number: 1045254-2014-00324
• 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,User Facility,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2014

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: 04/15/2022
• Device Model Number: 1885061HS
• Device Catalogue Number: 1885061HS
• Device Lot Number: 0208263123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided; 12/19/2014
• Supplement Dates FDA Received: 01/08/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1