MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® CLEARVIEW - LEGEND TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number SP14MH30

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2020

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 the burr was not spinning.Surgeon checked and the burr was broken off intraoperatively.There was no known patient impact.

Manufacturer Narrative

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

Event Description

Upon follow up it was confirmed that there was no reported fragments detached from the device.There was no patient impact.

Manufacturer Narrative

H3 the product analysis result indicates that the cutting tips from both burs were not attached and not returned which would have resulted in the reported event.The distal end of the outer assemblies were both deformed in the same relative direction and 1 had the inner bushing dislodged which is an indication of aggressive use.Both burs were destructively disassembled for additional analysis.Although the distal end of the shaft assemblies were not returned, they would have measured approximately 5.11¿ and 4.80¿ from tip to break point based off the location of the breaks.The break point corresponds to the proximal side of the outer tube radius where the diameter of the inner shaft is 0.024¿.When viewed under magnification, the fracture contained circular patterns and the high points were worn down which most likely indicates torsional overload caused the break and continued rotation caused the wear.The manufacturing instructions require a pull test on the bur head which would likely have detected this issue if present during production.There was no allegation of a defect prior to use.This event includes 2 burs from the same lot number breaking during use; a review of the global complaint data showed no other complaints for this lot number; this is the second similar complaint from this facility for the same part number within 6 months.The information most likely indicates erratic torsional loads due to aggressive use.The ifu warns the user not use excessive force to pry or push bone with the attachment or tool during dissection, this could cause the tool to break.H6: additional information suggest that fdm 4114 , fdr 3221 and fdc 67 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® CLEARVIEW - LEGEND TOOL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9768626
• MDR Text Key: 182005887
• Report Number: 1045254-2020-00113
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00643169308428
• UDI-Public: 00643169308428
• Combination Product (y/n): N
• PMA/PMN Number: K081277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: SP14MH30
• Device Catalogue Number: SP14MH30
• Device Lot Number: 0219098648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/20/2020; 04/16/2020
• Supplement Dates FDA Received: 04/11/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1