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

Model Number	SP12MH30
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr:  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 or Problem Description
A healthcare professional (hcp) reported via manufacturer representative that the tool broke near the tip (where the tip meets the shaft) during the 3rd.Final level of the acdf (anterior cervical discectomy and fusion) procedure.The cutting tip separated from the shaft, presumably at the weld point while drilling.There were no broken pieces that remain inside the patient's body.The tool was replaced with a different tool and the case was completed.There was no impact or injury to the patient.The only delay was how long it took to change the drill setup.
Additional Manufacturer Narrative
H3: analysis found that there was a residue consistent with biological contaminants on the device.Visually, the distal tip had broken off from the shaft which would have resulted in the reported event.The portion that detached measured 0.155¿ from tip to break.The configuration of the break was consistent with shear or bending stress.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.H6: additional information suggest that fdm:b21, fdr:c21 and fdc:d16 no longer apply 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.
Event or Problem Description
Additional information received mentioned that there were no fragments that got detached or came off from the bur.

• Brand Name: XPS CLEARVIEW - LEGEND TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 12480866
• Report Number: 1045254-2021-00523
• Device Sequence Number: 3736908
• Product Code: HBE
• UDI-Device Identifier: 00643169308497
• UDI-Public: 00643169308497
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Expiration Date: 04/07/2025
• Device Model Number: SP12MH30
• Device Catalogue Number: SP12MH30
• Device Lot Number: 0222048382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1