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

Model Number 1883672HS

Device Problem Material Fragmentation (1261)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/08/2022

Event Type  Injury  

Event Description

It was reported that during procedure during drilling, the tip of bur broke in several parts and got sucked into the frontal sinus and end stayed stuck into the shaver.Broken pieces of the reported product remain inside the frontal sinus and retrieved.A second incision was performed.Used a second motor and a second bur to remove the fragments.The motor was broken too.The procedure was completed with backup product(s).Patient alive with injury.There was surgical delay of 1 hour.

Manufacturer Narrative

Medical safety review: medical safety review task states that the reported event and its severity are known and labeled, per ifu 68e3858 f, which states excessive pressure applied to bur may cause bur fracture.Should a bur fracture occur during use; extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient.Unremoved bur fragments may cause tissue damage to the patient.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 15201094
• MDR Text Key: 297635725
• Report Number: 1045254-2022-00461
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2022

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 Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 02233663589
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/10/2022
• 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