MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE¿ SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV2132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
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
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis for stenosis.Procedure performed was mlif therapy.It was reported that while using mallet to insert implant, the joint on the inserter by the handle was broken.There was no fragment left in the patient.There were no symptoms reported.There were no further complications reported regarding the event.Inserter came into contact with patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis for stenosis.Procedure performed was mlif therapy.It was reported that while using mallet to insert implant, the joint on the inserter by the handle was broken.There was no fragment left in the patient.There were no symptoms reported.There were no further complications reported regarding the event.Inserter came into contact with patient.
Additional Manufacturer Narrative
H3: product analysis product id : nav2132, lot no.: dn19k002, visual and optical inspection revealed the inserter has broken at the inner threaded ring where the shaft and handle interface.The break has occurred at the locking tab cutouts.A microscopic analysis of the fracture surface indicates a brittle fracture.The fracture appears to have occurred from the material attempting to shift during compression.This is consistent with the instrument being struck from the back side.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: ELEVATE¿ SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12906223
• Report Number: 1030489-2021-01476
• Device Sequence Number: 4829045
• Product Code: OLO
• UDI-Device Identifier: 00763000141400
• UDI-Public: 00763000141400
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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 Model Number: NAV2132
• Device Catalogue Number: NAV2132
• Device Lot Number: DN19K002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male