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

Model Number 1883274HSE

Device Problem Break (1069)

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

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare professional (hcp) reported via manufacturer representative that during a joint neuro case -transpheniodal access surgery, the surgeon was using drill as per normal and the bur snapped.There was 20 minutes delay in the surgical procedure.There was no broken piece of the reported product remain inside the patient's body.The procedure was completed with backup product(s).The patient was alive - no injury.On follow-up, additional information was received that the event occurred while using on the patient.

Manufacturer Narrative

H3: analysis found that the inner shaft broke 0.23¿ from the inner hub's distal face, resulting in the reported malfunction.There were striations around the outside diameter of the breakpoint, indicating metal on metal contact during use.The breakpoint corresponds to the proximal end of the bushing in the front hub.There was no damage to the distal tip.When viewed under magnification, there was deformation and indentations of the front hub locking area consistent with aggressive use.There was no allegation of a defect before placement into the handpiece.There was no indication of device fragments, and the breakage would have contained by the outer tube and the handpiece.H6: fdm b17, fdr c20 and fdc d14 are no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by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 - DIAMOND
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10874031
• MDR Text Key: 217463716
• Report Number: 1045254-2020-00567
• Device Sequence Number: 1
• Product Code: EQJ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 1883274HSE
• Device Catalogue Number: 1883274HSE
• Device Lot Number: 0217711176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1