MAUDE Adverse Event Report: COVIDIEN LLC XPS SYSTEM NAVIGATED BLADE; INSTRUMENT, STEREOTAXIC

Model Number	1884006EM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
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 provider (hcp) reported that during operation when the doctor inserted blade into the patient and pressed the foot pedal, the blade blew up in her hand.Part of the shaver, the tip, separated from the rest of the shaver blade.There were no fragments detached.Box, package, nor product was not torn before opening and using.There was no patient impact.
Additional Manufacturer Narrative
H3: analysis found that visually, the middle spiral wrap was damaged at the distal end which would have resulted in the reported event.The spiral wrap was unwound in such a way that indicates torsional load while moving in a clockwise direction.There was no detachment of any components.There was some binding of the inner assembly while spinning it by hand which is likely the result of the damaged middle spiral wrap.The manufacturing instruction require ¿verify rotating hub spins within rotatable blade sheath¿, ¿verify rotating hub spins within irrigation collar¿, and ¿rotate the inner cutter/hub to align the edge of the window opening of the inner cutter in the center of the window opening of the outer tube¿.The manufacturing checks would likely be detected the damage ¿if¿ present during manufacturing.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.There was no allegation of a defect prior to use.The information most likely indicates the blade was being run in forward motion which caused friction and torsional load against the middle assembly unto the spiral became unwound.The product information and instructions warns: blades should be operated in the oscillate mode only; operating in the forward mode may cause damage to the blade.In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage).H6: fdm 4114 fdr 3221 fdc 67 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 SYSTEM NAVIGATED BLADE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 10708828
• Report Number: 9612501-2020-01496
• Device Sequence Number: 3630360
• Product Code: HAW
• UDI-Device Identifier: 00763000043254
• UDI-Public: 00763000043254
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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 Expiration Date: 01/19/2022
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0219215915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1