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

Model Number 1883672HS

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

There were 4 devices used in the surgery and we're submitting 4 mdrs for the same event list of products involved: bur 1883672hs 3pk hi speed diamond 70deg lot no.214029782 bur 1883672hs 3pk hi speed diamond 70deg lot no.214029782 bur 1883672hs 3pk hi speed diamond 70deg lot no.214029782 bur 1883672hs 3pk hi speed diamond 70deg lot no.216595673 if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a health care professional that during a frontal drill out the burs broke intra-op the doctor ended up opening 5 and the 5th one worked fine.On follow up it was reported that the bur broke while being used by the surgeon.The rear end was the part of the blade that broke.There was no mention about any fragments from the broken device.The piece that broke came off in one piece.

Manufacturer Narrative

H3 the product analysis result indicates that there were striations around the outside diameters of the breakpoints, indicating metal on metal contact during use, which would have resulted in the reported event.The breakpoint corresponds to the proximal end of the outer tube in the outer hub.There was no damage to the distal tip.There were no bends or signs of concentricity issues.There was no evidence of improper manufacturing therefore has been ruled out as a likely cause.A review of the global complaint data showed no other similar complaints about this lot number.There was no allegation of a defect prior to use.The information most likely indicates excess pressure was applied while in the handpiece during rotation which caused deformation of the locking area, friction within the assembly, and eventual breakage.The ifu warns: do not use burs above the speed indicated on the bur/blade; excessive pressure applied to the bur/blade may cause damage.H6: additional information suggest that fdm b17, fdr c20 and fdc d14 are no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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
• MDR Report Key: 11912958
• MDR Text Key: 254538467
• Report Number: 1045254-2021-00267
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00721902100567
• UDI-Public: 00721902100567
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0214029782
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1