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

Model Number 31130571

Device Problem Material Fragmentation (1261)

Patient Problems Nerve Damage (1979); Vertigo (2134)

Event Date 06/03/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: analysis results are not available; device not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Per sus voluntary event report: mw5070751: "rough fine diamond bur 0.5 mm used to drill cochleostomy.Pt had thick bone and needed increased drilling, at the end of the drilling the drill tip broke off.The surgeon had difficulty removing the broken tip because it had lodged into the bone so he ended up making the cochleostomy wider which may have caused injury to the facial nerve.Post op vertigo.".

• Brand Name: XPS® BUR
• 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 dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6788984
• MDR Text Key: 82516130
• Report Number: 1045254-2017-00280
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074496641
• UDI-Public: 00885074496641
• 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,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2018
• Device Model Number: 31130571
• Device Catalogue Number: 31130571
• Device Lot Number: 0208485821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention