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

Model Number 1883672HS

Device Problems Use of Device Problem (1670); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Analysis found that the inner shaft was bent until broken, the spiral wrap was stretched, the irrigation barb was deformed, and there were tool marks along the length of the bur.The outside diameter of the inner hub showed deformation.The inner hub outside diameter requirement is 0.330¿ / +-0.002¿ and measured 0.329¿ in the undamaged area and 0.362¿ in the deformed area which is out of specification.The hub bushings were gouged as well.If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider (hcp) reported that the device was not working properly.The bur was stuck in the shaver prior to the procedure.There was no patient impact.

• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8147515
• MDR Text Key: 130048938
• Report Number: 1045254-2018-00694
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2018

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 Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/10/2018
• 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