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

Model Number	1883070HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by a health care professional that the tip of drill bit was broken during surgery.There was no broken piece of the reported product that remained inside the patient's body.The procedure was completed by a back up product with no delay.There was no patient impact.Upon follow up it was reported that the blade broke while being used on a patient.
Additional Manufacturer Narrative
H3 the product analysis result indicates that the inner spiral wrap was stretched which would have resulted in the reported event.The tip was extending beyond the support area of the outer tube by 0.544¿.There was gouging and thinning of the distal outer tube¿s wall thickness indicating that excessive pressure was applied to the bur while being used.There were no loose components.There are inspections for damage throughout the manufacturing process.There was no allegation of a defect prior to use.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.A review of the global complaint data showed no other complaints about this lot number.The information most likely indicates that aggressive use resulted in the damage to the spiral wrap.The user guide warns: bending or prying may break the accessory; do not use excessive force to pry or push bone with the attachment, tool, or blade during dissection; excessive pressure applied to the bur may cause bur fracture.H6: additional information suggest that fdm b18 , fdr c20 and fdc d14 are no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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 - HIGH SPEED RAD
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 12198035
• Report Number: 1045254-2021-00384
• Device Sequence Number: 19710322
• Product Code: EQJ
• UDI-Device Identifier: 00681490464604
• UDI-Public: 00681490464604
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0217848908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1