MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number 1883672HS

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2015

Event Type  malfunction  

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4) - no consequences or impact to patient.(b)(4).The product analysis found the following: condition upon receipt: 1 un-sealed sample, part number 1883672hs, from lot number hg05t32 received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide]¿ visually, the distal tip had broken off which would have resulted in the reported event.The portion that became detached measured 0.47¿.When viewed under magnification, the break point, the spiral wrap had turned in on itself in a clockwise direction indicating the device was turning clockwise when it broke and excess torsional load contributed to the breakage.The diamond grit at the tip was compacted with bone-like material and the inside diameter of outer tube near the break point was gouged which may indicate excess pressure was use during use however this cannot be confirmed.

Event Description

It was reported that the bur got broken during surgery.The fragment fell in patient's body, and was retrieved.The patient got surgery due to frontal sinus cyst.The surgery was completed using a rongeur, but not efficient due to no drill.Now the patient is well.

• Brand Name: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 5379668
• MDR Text Key: 36647007
• Report Number: 3004209178-2016-00751
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/28/2015

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: 06/06/2022
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: HG05T32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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 Age: 00063 YR