MAUDE Adverse Event Report: COVIDIEN LLC XPS BUR; BUR, EAR, NOSE AND THROAT

Model Number	1885061HS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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
A healthcare professional (hcp) reported via manufacturer representative that during a procedure for pituitary surgery, the connection at the base of the bur broke or came off during drilling.A backup product was used, but the same issue occurred.There was a 10-minute delay in the surgical procedure.The procedure was completed with backup product(s).The patient was alive.No injury.
Additional Manufacturer Narrative
H3: analysis found visually, the inner shafts for both samples broke 0.71¿ from the distal face of the inner hub which would have resulted in the reported event.There was no damage to the distal tip on either sample.Under magnification, both samples had striations around the outside diameter of the break point indicating metal on metal contact during use.One of the samples had dents on the chevrons on the proximal end of the inner hub indicating improper loading into the handpiece.The other sample had indentations and scratches on the inner and front hubs that was consistent with aggressive use.There was no allegation of a defect prior to use.H6: fdm b17, fdr c20, fdc d14 no longer apply.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
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 12274340
• Report Number: 9612501-2021-01285
• Device Sequence Number: 4495398
• Product Code: EQJ
• UDI-Device Identifier: 00681490693066
• UDI-Public: 00681490693066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 1885061HS
• Device Catalogue Number: 1885061HS
• Device Lot Number: 0220659672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1