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

Model Number 1883212HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was discarded by the user and will not be returned for analysis.

Event Description

It was reported that the high speed bur broke in the area near the handpiece during surgery.There was no patient impact.

Manufacturer Narrative

Initial reporter and facility information was provided: (b)(6).

Manufacturer Narrative

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): MEDYRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 5338504
• MDR Text Key: 35257322
• Report Number: 1045254-2015-00443
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2015

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: 1883212HS
• Device Catalogue Number: 1883212HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided; 01/20/2016
• Supplement Dates FDA Received: 01/21/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1