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

Model Number 1883672HS

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: analysis results not available; the devices were 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

It was reported that "two drills broke themselves in the nose during their use in the course of surgical operation." there was no reported patient impact.

Manufacturer Narrative

Event Description

Additional information received confirming that during a frontal sinus procedure, "as the burs were broken in the nose, some fragment were detached but the surgeon didn¿t have problems to pick it up.The surgeon has used instruments to retrieve the fragment ¿ no fragments remained in the patient.".

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

We originally reported 2 burs on mdr 1045254-2016-00374.This report is being submitted for the product analysis of the first bur, a subsequent supplemental report will be filed for the product analysis of the second bur.Product evaluation: the hi speed diamond 70deg bur, part number 1883672hs, from lot number 0209955643, was received for analysis.There was a residue consistent with biological contaminants on the devices.Biological contaminants were found to be compacted in the diamond grit which likely resulted in the customer applying excess pressure to the bur in an attempt to maintain performance.When viewed under magnification there was evidence of aggressive use; gouging of the outside diameter of the inner shaft just proximal to the tip; and corresponding damage to the outer tube support area (including a thinning of the wall).Visually, the inner assembly tip broke off at the spiral wrap which would have resulted in the reported event.The section measured 0.50¿ from the tip to the break point.The spiral wrap was twisted in on itself in a clockwise direction at the break point.The location of the break is consistent with excessive torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the break.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information found during the product analysis: the spiral wrap stretched and the tip detached from the first bur; the spiral wrap stretched but remained intact for the second bur.

• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 6075284
• MDR Text Key: 59135041
• Report Number: 1045254-2016-00374
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 03/27/2018

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: 08/03/2023
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0209955643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; 02/16/2017; 02/16/2017; 03/15/2018
• Supplement Dates FDA Received: 02/21/2017; 09/26/2017; 09/29/2017; 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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: 45 YR