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

Model Number 1883670HS

Device Problems Break (1069); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 1883672hs: bur; 1883672hs 3pk hi speed diamond 70deg, lot 0210983179 manufactured: 03/16/2016 use before: 03/14/2024.Product evaluation: 1883670hs: upon analysis, when compared to the assembly drawing: visually, the spiral wrap broke which would have resulted in the reported event.The section measured 1.9 from the tip to the break point.When viewed under magnification, there was gouging of the outside diameter of the inner shaft just proximal to the tip with corresponding damage to the outer tube support area (including a thinning of the wall).The inner shaft was gouged 0.67 from the distal face of the inner hub.The spiral wrap was twisted in on itself in a clockwise direction at the break point.The location of the break indicates a torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the break.The information most likely indicates torsional load from use, combined with excess pressure, caused friction, which resulted in the gouging and subsequent break.The instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure required for operation].1883672hs: upon analysis, when compared to the assembly drawing: visually, the spiral wrap broke which would have resulted in the reported event.The section measured 1.7 from the tip to the break point.When viewed under magnification, there was gouging of the outside diameter of the inner shaft just proximal to the tip with corresponding damage to the outer tube support area (including a thinning of the wall).The spiral wrap was twisted in on itself in a clockwise direction at the break point.The location of the break indicates a torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the break.The information most likely indicates torsional load from use, combined with excess pressure, caused friction, which resulted in the gouging and subsequent break.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure requi red for operation].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

It was reported that during frontal sinus tumor resection, the blades got broken during surgery.The breaks did not result in fragments.The doctor replaced new one to complete the surgery.Now the patient is well.

Manufacturer Narrative

(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 dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6104090
• MDR Text Key: 59976524
• Report Number: 1045254-2016-00387
• 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,Followup,Followup
• Report Date: 10/24/2016

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: 02/20/2024
• Device Model Number: 1883670HS
• Device Catalogue Number: 1883670HS
• Device Lot Number: 0210864805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided; 04/03/2017
• Supplement Dates FDA Received: 04/03/2017; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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: 24 YR