MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC VANTAGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9339040
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis-t9-t10 infection involved in thoracic corpectomy procedure.Levels implanted- t9.It was reported that during procedure, the screwdriver was ¿stripped¿, would not hold screw.Instrument did not broke, deformed tip (stripped) hex driver tip.Product was utilized correctly according to the directions given in the ifu/labeling.On 2021-mar-08, received additional information that initial surgery was performed with original products, but not completed.On (b)(6) 2021, patient returned for additional surgery, inclusive of additional treatment to complete surgery from(b)(6) 2021.The surgery on (b)(6) 2021 was delayed while they tried to lock the vantage plate.Approximate delay was 30-45 minutes.No patient symptoms/complications reported.
Additional Manufacturer Narrative
H3: device evaluated summary: visual and optical examination identified that part of the tip of the hex driver has been sheared off, consistent with interface during usage and was not returned for analysis.Material hardness tested and was found to be within specification.This is consistent with overload.Additional information: d9, g3, h3, h6.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: VANTAGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11543544
• Report Number: 1030489-2021-00380
• Device Sequence Number: 4602517
• Product Code: LXH
• UDI-Device Identifier: 00721902692604
• UDI-Public: 00721902692604
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9339040
• Device Catalogue Number: 9339040
• Device Lot Number: JT03H002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR