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

Model Number 1883070HS

Device Problems Break (1069); Device Inoperable (1663); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure 4 burs, 3 from one lot and then 1 other from a different lot, sustained spiral wrap breaks, they ¿bur broke internally and stopped working¿.It was also reported that one of the bur tips broke off and the surgeon ¿did have to retrieve the severed tip from the nose.¿ after the fourth break, the surgeon switched to a different drill and different type of bur to finish the case.There was no patient impact.

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant medical products: unknown bur, lot number unknown (b)(4).

Manufacturer Narrative

Date of this report: 04/22/2015.Date received by manufacturer: 05/21/2015.Product evaluation: received 1 sample, part number 1883070hs, for analysis.There was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].The sample was analyzed.The distal tip was pulled out from the outer tube indicating a stretched and broken spiral wrap.The sample had gouging on the inner shaft in the support area and corresponding damage to the outer tube which indicates excess pressure.There were no missing pieces from the device.Note: [excess: exceeded sufficient pressure required for operation].Instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.Method: actual device evaluated.(b)(4).

Manufacturer Narrative

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

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• 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 drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4774922
• MDR Text Key: 5800341
• Report Number: 1045254-2015-00168
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2015

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 Expiration Date: 01/10/2020
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0205664033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided; 05/21/2015
• Supplement Dates FDA Received: 05/22/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00045 YR
• Patient Weight: 70