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

Model Number 1883262HS

Device Problem Break (1069)

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

Event Date 10/14/2014

Event Type  malfunction  

Event Description

It was reported to the sales rep that three blades broke during the same case.All three were from the same lot number.All three blades broke while the doctor was drilling the bone.Nothing detached from the blade and there were no fragments.After the third blade broke, they did not have anymore blades of part # 1883262hs.The customer used a different blade to finish the procedure with no further issues.There was no injury reported as a result of this event.

Manufacturer Narrative

(b)(4).The devices have been received.However, the product analysis has not yet been completed.Method code: no testing methods performed.This device is used for therapeutic purposes.

Manufacturer Narrative

The product analysis was completed on november 11, 2014.The product analysis indicates that three samples (1883262hs) were returned for analysis.The inner shafts turn by hand.However, they do not turn smoothly.When compared to the inner assembly drawing 90a1471 revision a, outer assembly drawing 90a1470 revision 00 and viewed under magnification, there was no damage to the tip and no apparent external damage that would result in the reported malfunction.The inner shaft was removed and there was gouging around the outside diameter 1.3¿ from the distal face of the inner hub which corresponds to the step down in the diameter of the outer tube.The information indicates metal on metal contact between the inner and outer tubes.There was discoloration on the outer tube of one of the samples which is likely caused by excess pressure combined with friction induced heat.There was no evidence of improper manufacturing therefore manufacturing has been ruled out as a potential cause.The instructions for use warn that bending, prying, and excessive pressure may cause damage to the bur.(b)(4).

Manufacturer Narrative

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

• Brand Name: ROUND BUR, HIGH SPEED
• 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 n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive n; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 4237043
• MDR Text Key: 5075838
• Report Number: 1045254-2014-00287
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2014

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: 05/05/2022
• Device Model Number: 1883262HS
• Device Catalogue Number: 1883262HS
• Device Lot Number: 0208328219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 11/07/2014
• Supplement Dates Manufacturer Received: Not provided; 11/11/2014
• Supplement Dates FDA Received: 12/04/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 93