MAUDE Adverse Event Report: XPS® SYSTEM NAVIGATED BLADE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 1884006EM

Device Problem Material Separation (1562)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available as of the date of this  report.  a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by health care professional that the first blade's tip came off during endoscopic sinus surgery.The procedure was completed with backup product(s) there was no patient impact.Upon follow up it was reported that the event happened during use, there was no fragments detached/came off from the broken device and none fell into the patient's body.

Manufacturer Narrative

H3: the product analysis result indicates that middle assembly tip had been pushed out of the outer tube support area, indicating spiral wrap damage.The middle assembly would bind when turned by hand and, the inner assembly did not spin freely by hand.The information most likely indicates an interference issue of the diameters during manufacturing, resulting in the reported event.The product instruction requires production to "rotate hub/cutter assembly in hub/outer tube assembly; there shall be no resistance or unusual grinding noises.There was evidence to support improper manufacturing.H6: additional information suggest that fdm b21, fdr c21 and fdc d16 are no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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® SYSTEM NAVIGATED BLADE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• MDR Report Key: 12488093
• MDR Text Key: 271901378
• Report Number: 9612501-2021-01544
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K130608
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0220804521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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