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

Model Number 311720115E

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported that during a mastoidectomy, the distal portion of the curved bur (head of the bur) broke at the beginning of its use, all fragments were collected.There was a procedure delay.There was no patient impact.

Manufacturer Narrative

Analysis found visually, the distal cutting tip broke off which would have resulted in the reported event.The portion that became detached measured 0.13¿.The break location corresponds to the distal end of the outer tube after assembly.The configuration of the break was consistent with shear or bending stresses.The nominal shaft diameter at the break is 0.020¿ and should not be subjected to bending or prying.The cutting flutes were rough and worn distal to the center line of the head.The remainder of the inner shaft assembly was pulled out of the outer assembly and bent.The proximal tang which locks into the handpiece (when properly loaded) was rough and worn indicating at some point the bur was improperly engaged with the handpiece drive mechanism.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 dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9523479
• MDR Text Key: 175198039
• Report Number: 1045254-2019-00704
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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: 07/15/2023
• Device Model Number: 311720115E
• Device Catalogue Number: 311720115E
• Device Lot Number: 0218101724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• 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