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

Model Number	SP12MH30
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
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
It was reported that when the surgeon was using the drill bit, it broke.The parts of the broken drill bit were all collected.There was no known impact or consequence to patient.The intended procedures were lumbar 4-lumbar 5 and lubar 5 scal one hemilaminectomies, medial facetectomies, foraminotomies, posterior instrumented fusion, possible interbody fusion, allograft, auto graft, possible bone morphogenic protein.Upon follow up it was confirmed that another drill bit was used in the surgery, there was no significant delay, the surgeon was using fluoroscope, that aid the doctor in getting all of the fragments, using forceps (tweezers).To confirm, the surgical tech in the or, compared the pieces of the broken drill bit they had to the whole drill bit used to complete the surgery, and believed they retrieved all of the pieces/ fragments.The device was in the container and looked 2 good size pieces broke.There was no patient impact.
Additional Manufacturer Narrative
H3 the product analysis result indicates that there was a residue consistent with biological contaminants on the device.Visually, the tip had broken off the distal end of the shaft which would have resulted in the reported event.The portion that became detached measured 0.171¿ from tip to break.The configuration of the break is consistent with shear or bending stress.The nominal shaft diameter at the break is 0.035¿.The location of the break corresponds to the (0.040¿) area of the shaft that extends beyond the outer assembly.The manufacturing instructions require a pull test on the head of the bur which does not generate sheer or bending stress.There was no allegation of a defect prior to use.The cutting flutes of the tip were rough and worn which may indicate aggressive use.A review of the global complaint data showed no other complaints for this lot number.The user¿s guide warns, do not use excessive force to pry or push bone with the attachment or tool during dissection, this could cause the tool to break.The complaint substantiated.In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage).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
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10579836
• Report Number: 1045254-2020-00428
• Device Sequence Number: 19623553
• Product Code: HBE
• UDI-Device Identifier: 00643169308497
• UDI-Public: 00643169308497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 06/17/2024
• Device Model Number: SP12MH30
• Device Catalogue Number: SP12MH30
• Device Lot Number: 0220236421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 182